This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

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This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements. This document is applicable to polymer-based crown and veneering materials for laboratory fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

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This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations.
This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.
For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

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This document specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices.
This document is applicable to dentifrices, including toothpastes, destined to be used by consumers on a daily basis with a toothbrush to promote oral hygiene.
This document does not apply to specific qualitative and quantitative requirements for freedom from biological and toxicological hazards. These are covered in ISO 7405 and ISO 10993-1.

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This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
NOTE            Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (e.g. headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

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This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations.
This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.
For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

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This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

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This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
NOTE            Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (e.g. headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

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This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials.
This document is applicable to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators can be powered by an internal power supply (rechargeable battery powered) or can be powered by external (mains) power or can be powered by a dental unit. Lasers or plasma arc devices are not covered by this document.
This document does not apply to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

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This document classifies denture adhesives used by wearers of removable dentures. It also specifies requirements, test methods and instructions to be supplied for the use of such products.
This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.

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This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments. This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments. NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document. This document does not apply to stationary dental equipment, wearable equipment (e.g. headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

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This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials.
This document is applicable to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators can be powered by an internal power supply (rechargeable battery powered) or can be powered by external (mains) power or can be powered by a dental unit. Lasers or plasma arc devices are not covered by this document.
This document does not apply to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

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This document specifies requirements and test methods for measuring the accuracy of electronic apex locators that are used to determine the apex location during endodontic treatment.

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This document specifies requirements and test methods for operating lights used in dental treatment and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.

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This document specifies coupling between handpieces and motors that are connected to dental units. For the purposes of this document, the couplings described in this document are not equipped with electronic terminal(s).
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.

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This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This document is applicable to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators can be powered by an internal power supply (rechargeable battery powered) or can be powered by external (mains) power or can be powered by a dental unit. Lasers or plasma arc devices are not covered by this document. This document does not apply to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

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This document specifies requirements and test methods for measuring the accuracy of electronic apex locators that are used to determine the apex location during endodontic treatment.

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This document specifies coupling between handpieces and motors that are connected to dental units. For the purposes of this document, the couplings described in this document are not equipped with electronic terminal(s).
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.

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This document specifies requirements and test methods for measuring the accuracy of electronic apex locators that are used to determine the apex location during endodontic treatment.

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This document specifies requirements and test methods for operating lights used in dental treatment and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.

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This document specifies coupling between handpieces and motors that are connected to dental units. For the purposes of this document, the couplings described in this document are not equipped with electronic terminal(s). This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.

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This document specifies requirements and test methods for operating lights used in dental treatment and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging. This document applies to operating lights, irrespective of the technology of the light source. This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.

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This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:
implant body;
implant abutment;
abutment screw;
implant connecting part;
implant connecting part screw;
prosthetic screw;
implant cover screw;
transmucosal healing component.
This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
This document does not apply to the following devices:
dental implants incorporating animal or human components or bioactive characteristics;
custom-made devices that have no pre-fabricated connection;
implantable materials for bone filling and augmentation in oral and maxillofacial surgery;
membrane materials for guided tissue regeneration in oral and maxillofacial surgery;
specific instruments indicated to be used as part of a dental implant system.
NOTE 1        ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2        ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3        Custom-made devices are defined in IMDRF/PMD WG/N49 [5].

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This document defines terms and definitions used in the process chain for computer-aided design and computer-aided manufacturing (CAD/CAM) systems in dentistry.
NOTE: See Annex A for a flow chart of the process chain.

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This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:
implant body;
implant abutment;
abutment screw;
implant connecting part;
implant connecting part screw;
prosthetic screw;
implant cover screw;
transmucosal healing component.
This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
This document does not apply to the following devices:
dental implants incorporating animal or human components or bioactive characteristics;
custom-made devices that have no pre-fabricated connection;
implantable materials for bone filling and augmentation in oral and maxillofacial surgery;
membrane materials for guided tissue regeneration in oral and maxillofacial surgery;
specific instruments indicated to be used as part of a dental implant system.
NOTE 1        ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2        ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3        Custom-made devices are defined in IMDRF/PMD WG/N49 [5].

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This document defines terms and definitions used in the process chain for computer-aided design and computer-aided manufacturing (CAD/CAM) systems in dentistry.
NOTE: See Annex A for a flow chart of the process chain.

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This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include: implant body; implant abutment; abutment screw; implant connecting part; implant connecting part screw; prosthetic screw; implant cover screw; transmucosal healing component. This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer. This document does not apply to the following devices: dental implants incorporating animal or human components or bioactive characteristics; custom-made devices that have no pre-fabricated connection; implantable materials for bone filling and augmentation in oral and maxillofacial surgery; membrane materials for guided tissue regeneration in oral and maxillofacial surgery; specific instruments indicated to be used as part of a dental implant system. NOTE 1 ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file. NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file. NOTE 3 Custom-made devices are defined in IMDRF/PMD WG/N49 [5].

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This document defines terms and definitions used in the process chain for computer-aided design and computer-aided manufacturing (CAD/CAM) systems in dentistry. NOTE: See Annex A for a flow chart of the process chain.

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This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1        Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2        National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.

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This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1        Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2        National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.

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This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.

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This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.

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This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry. This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2). The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy. This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made. NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.

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This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.

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This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.

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This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use.
Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration.
Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.

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This document specifies requirements and test methods for acid-base, dental cements intended for permanent cementation, lining and restoration. This document is not intended to address resin-modified water-based cements. This document is applicable to both hand-mixed and encapsulated cements for mechanical mixing. This document specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, base or liner, restorative material or pit and fissure sealing cement.

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This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.

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This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.

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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.

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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.

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This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use.
Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration.
Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.

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This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.

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This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use. Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration. Clause 7 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0037000000 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.

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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.

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This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.

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This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.

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