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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 061 Date of Entry 12/18/2023 
FR Recognition Number 4-311
Standard
ISO  9917-2 Third edition 2017-09
Dentistry - Water-based cements - Part 2: Resin-modified cements
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 9917-2 Second edition 2010-04 [Rec# 4-188] will be superseded by recognition of ISO 9917-2 Third edition 2017-09 [Rec# 4-311]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-188] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-188] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3275 Cement, Dental Class 2 EMA
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Dental Cements - Premarket Notification Document, issued August 1998.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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