Dentistry Materials Standards
Materials and amalgams used in dentistry adhere to requirements to assure compatibility with both the human body and the equipment used to manipulate them. These standards provide guidance on testing wear, adhesion, compatibility, and corrosion, as well as setting out requirements and test methods for materials. Packaging and marking requirements are also included, to provide consistency and reliability in the use of dental materials.
ANSI/ADA 99-2001 (R2013)
Athletic Mouth Protectors and Materials
This specification is for thermoplastic or thermosetting polymeric materials, with or without a polymeric shell, that are capable of being formed into an athletic mouth protector, either on a model of the teeth or in the mouth directly on the teeth. It lists the types and classes of mouth protectors and lists requirements for physical properties along with tests specified for determining compliance with those requirements It also specifies requirements for manufacturer's instructions and for packaging, labeling, and marking.
ANSI/ADA 139-2012
Dental Base Polymers
This part of ANSI/ADA Standard No. 139 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used.
ANSI/ADA 57-2000 (R2012)
Endodontic Sealing Materials
This specification is for materials used in endodontics within the tooth to seal the root canal space.
ISO 3107:2011
Dentistry - Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
ISO 3107:2011 specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations. ISO 3107:2011 also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.
ISO 4049:2019
Dentistry - Polymer-based restorative materials
This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting. The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506). The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).
ISO 4823:2021
Dentistry - Elastomeric impression and bite registration materials
This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.
ISO 6872:2015
Dentistry - Ceramic materials
ISO 6872:2015 specifies the requirements and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.
ISO 6874:2015
Dentistry - Polymer-based pit and fissure sealants
ISO 6874:2015 specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth. It covers both self-curing and external-energy-activated materials.
ISO 7405:2018
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
ISO 7488:2018
Dentistry - Mixing machines for dental amalgam
ISO 7488:2018 specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam. ISO 7488:2018 specifies the test methods used to determine conformity with these requirements. ISO 7488:2018 refers to those machines that mix by an oscillating action and which are sold by the manufacturer for the purpose of mixing dental amalgam whether or not they are intended for mixing any other type of product. ISO 7488:2018 does not specify requirements for removable mixing-capsules, as are used in many machines to contain the material to be mixed, although considered as part of the machine when in use or under test.
ISO 7491:2000
Dental materials -- Determination of colour stability
This International Standard specifies a method for the determination of the colour stability of dental materials after exposure to light and water.
ISO 8282:1994
Dental equipment -- Mercury and alloy mixers and dispensers
Specifies requirements and test methods for devices used for dispensing dental amalgam alloys and/or mercury. Includes the dispensing portion of devices which dispense the correct portions of alloy and mercury as well as mix the amalgam in a single, continuous operation. Does not specify requirements and test methods for the efficacy of mixing.
ISO 9333:2006
Dentistry - Brazing materials
ISO 9333:2006 specifies requirements and test methods for brazing materials suitable for use in metallic restorations.
ISO 9693:2019
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
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.
ISO 9693:2019
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
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.
ISO 9917-1:2007
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
ISO 9917-1:2007 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. ISO 9917-1:2007 is applicable to both hand-mixed and capsulated cements for mechanical mixing. ISO 9917-1:2007 specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a base or liner or as a restorative material. ISO 9917-1:2007 is not intended to address resin-modified water-based cements.
ISO 9917-2:2017
Dentistry - Water-based cements - Part 2: Resin-modified cements
ISO 9917-2:2017 specifies requirements and test methods for water-based dental cements in which setting is achieved by a combination of an acid-base reaction and polymerization. The materials are intended for luting, base or lining, restoration and tooth core build up purposes. EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this document will normally be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to undergo setting by polymerization. NOTE The attention of manufacturers and test laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917 1 so that they can consider which is the most appropriate for evaluating any individual product.
ISO 10139-1:2018
Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
ISO 10139-1:2018 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.
ISO 10139-2:2016
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
ISO 10139-2:2016 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.
ISO 10271:2020
Dentistry - Corrosion test methods for metallic materials
This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials. This document is not applicable to dental instruments.
ISO 10477:2020
Dentistry - Polymer-based crown and veneering materials
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.
ISO 10873:2021
Dentistry - Denture adhesives
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.
ISO 11143:2008
Dentistry - Amalgam separators
ISO 11143:2008 specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, instructions for use, operation and maintenance. All tests described in ISO 11143:2008 are type tests.
ISO/TS 11405:2015
Dentistry - Testing of adhesion to tooth structure
ISO/TS 11405:2015 gives guidance on substrate selection, storage, and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It includes a tensile bond strength measurement test, a test for measurement of marginal gaps around fillings, a microleakage test, and gives guidance on clinical usage tests for such materials. Some specific test methods for bond strength measurements are given for information in Annex A. ISO/TS 11405:2015 does not include requirements for adhesive materials and their performance.
ISO 13897:2018
Dentistry - Dental amalgam reusable mixing-capsules
ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements. NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.
ISO 14233:2003
Dentistry - Polymer-based die materials
ISO 14233:2003 gives compositional, performance, user-information, packaging and marking, and testing requirements for polymer-based die materials used in dentistry. It is applicable to die materials having a polymeric matrix as their principal constituent. Polymer-based die materials are used in the dental laboratory mainly to produce casts from dental impressions for the manufacture of fixed or removable restorations)
ISO 14356:2003
Dentistry - Duplicating material
ISO 14356:2002 specifies requirements and tests for the duplicating materials used in dentistry which are primarily intended for forming flexible moulds needed to produce positive refractory investment copies of properly blocked-out master models.
ISO/TR 14569-1:2007
Dental materials - Guidance on testing of wear - Part 1: Wear by toothbrushing
ISO/TR 14569-1:2007 provides guidelines for test methods for the assessment of resistance to wear by tooth brushing for the following materials: materials used for the preparation of artificial teeth; veneering of crowns and bridges.
ISO/TS 14569-2:2001
Dental materials - Guidance on testing of wear - Part 2: Wear by two- and/or three body contact
This part of ISO/TS 14569 specifies test methods for the assessment of resistance to wear of materials occurring on the occlusal surfaces of restorations, in or on natural teeth or on artificial teeth, as a result of physiological activity in the mouth. Some of the proposed methods include wear from foodstuff as well as, or only, wear by direct contact. The test methods shown in Table 1 are described. This part of ISO/TS 14569 is not applicable to phenomena such as the marginal degradation and loss of substance by chemical processes, swelling, splintering of edges, or wear from toothbrushing.
ISO 15854:2021
Dentistry - Casting and baseplate waxes
This document specifies the classification of and requirements for dental casting and dental baseplate waxes together with the test methods to be employed to determine compliance with these requirements. This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based procedures.
ISO 15912:2016
Dentistry - Refractory investment and die material
ISO 15912:2016 gives requirements and test methods for determining the compliance of dental casting investment, dental brazing investment, dental pressable-ceramic investment and dental refractory die materials used in the dental laboratory, regardless of the composition of the refractory powder, the composition of the binder, or the particular application. ISO 15912:2016 classifies such products into types and classes, according to their intended use and the burn-out procedure recommended by the manufacturer. It also gives requirements for marking, labelling and manufacturer's instructions. It specifies requirements for the essential physical and mechanical properties of the products and the test methods to be used for determining them. NOTE 1 Compliance with all of the requirements presented in Clause 5 may not be necessary for some products, and a requirement might not be applicable to a product with a particular binder chemistry or be intended for an application in which that requirement is irrelevant. When this is the case, a clear statement to this effect is given according to Clause 5. NOTE 2 A specific quantitative requirement for setting expansion is not included in this International Standard. If the setting expansion of gypsum-bonded investment is measured, then the procedure given in ISO 6873[1] can be considered ? a procedure not recommended, however, for investment materials with other binders.
ISO 17304:2013
Dentistry - Polymerization shrinkage: Method for determination of polymerization shrinkage of polymer-based restorative materials
ISO 17304:2013 specifies a test method for the measurement of the polymerization shrinkage of external energy-activated polymer-based restorative materials such as composites and core materials.
ISO/TS 17988:2020
Dentistry - Corrosion test methods for dental amalgam
This document gives the details of test procedures for evaluating the corrosion resistance of dental amalgam formed from products that are within the scopes of ISO 24234 and ISO 20749 . This document is not applicable to other metallic materials in which an alloy powder reacts with a liquid alloy to produce a solid metallic material intended for dental restoration.
ISO 20795-1:2013
Dentistry - Base polymers - Part 1: Denture base polymers
ISO 20795-1:2013 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore, it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. ISO 20795-1:2013 applies to denture base polymers such as those listed below: poly(acrylic acid esters); poly(substituted acrylic acid esters); poly(vinyl esters); polystyrene; rubber modified poly(methacrylic acid esters); polycarbonates; polysulfones; poly(dimethacrylic acid esters); polyacetals (polyoxymethylene); copolymers or mixtures of the polymers listed in 1 to 9.
ISO 20795-2:2013
Dentistry - Base polymers - Part 2: Orthodontic base polymers
ISO 20795-2:2013 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.
ISO 21530:2004
Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants
ISO 21530:2004 specifies test methods for determining the resistance to chemical disinfectants of all materials used for external surfaces of dental equipment intended for such disinfection. Three test methods are specified: an immersion test, a spray test and a contact test. The choice of test method to be used is left to the discretion of the party conducting the testing. ISO 21530:2004 does not address the bactericidal, virucidal and fungicidal effectivity of the disinfectants. ISO 21530:2004 does not provide for testing the possible detrimental effects of applied stress on the resistance of test materials to the test reagents.
ISO 21563:2021
Dentistry - Hydrocolloid impression materials
This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.
ISO 22674:2016
Dentistry - Metallic materials for fixed and removable restorations and appliances
ISO 22674:2016 classifies metallic materials that are suitable for the fabrication of dental restorations and appliances, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. Furthermore, it specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for the use of these materials, including products delivered for sale to a third party. ISO 22674:2016 does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).
ISO 22794:2007
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.
ISO 22803:2004
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality, b) in contact with teeth and/or dental implants, c) for prevention of epithelial migration in periodontal surgery, d) for the augmentation of bone prior to the planned insertion of dental implants, e) and/or for augmentation of bone for stabilization of dental prostheses. This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.
ISO 24234:2021
Dentistry - Dental amalgam
This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury that are suitable for the preparation of dental amalgam together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking. NOTE Two of the requirements apply only to dental mercury (as supplied). All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam. This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. This document applies to products used to make dental amalgam restorations, supplied to the user in the following forms: dental amalgam alloy as a fine free flowing powder, or as a fine powder compacted into tablets and dental mercury in dental mercury sachets (sometimes referred to as dental mercury pillows). The mass of dental mercury in these sachets is limited to the amount required to make a small to medium-sized restoration in a single tooth. This document is not applicable to dental mercury that is supplied in a primary container in an undivided mass that exceeds the amount suitable for a small to medium-sized restoration.
ISO 29022:2013
Dentistry - Adhesion - Notched-edge shear bond strength test
ISO 29022:2013 specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.
