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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 065 Date of Entry 12/22/2025 
FR Recognition Number 4-348
Standard
ISO  9917-1 Third Edition 2025-05
Dentistry - Water-based cements - Part 1: Acid-base cements
Scope/Abstract
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.
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FDA recognition of ISO 9917-1 Second edition 2007-10-01 [Rec# 4-153] will be superseded by recognition of ISO 9917-1 Third Edition 2025-05 [Rec# 4-348]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-153] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 4-153] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3200 Agent, Tooth Bonding, Resin Class 2 KLE
§872.3275 Cement, Dental Class 2 EMA
§872.3765 Sealant, Pit And Fissure, And Conditioner Class 2 EBC
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff Dental Cements - Premarket Notification Document, issued August 1998.

2. Dental Cements - Performance Criteria for Safety and Performance Based Pathway, issued September 2024.

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
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  Michael.Adjodha@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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