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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 062 Date of Entry 05/29/2024 
FR Recognition Number 4-325
Standard
ANSI ADA  Standard No. 96-2020
Dental Water-based Cements
Scope/Abstract
Part 1 of ADA Standard No. 96 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. Part 1 is applicable to both hand-mixed and capsulated cements for mechanical mixing. Part 1 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. Part 1 of this standard is not intended to address resin-modified water-based cements, which are addressed in Part 2.
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FDA recognition of ANSI ADA Standard No. 96-2012 [Rec# 4-215] will be superseded by recognition of ANSI ADA Standard No. 96-2020 [Rec# 4-325]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-215] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 4-215] 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
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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