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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 047 Date of Entry 08/21/2017 
FR Recognition Number 4-215
Standard
ANSI ADA  Standard No. 96-2012
Dental Water-based Cements
Scope/Abstract
Part 1 of this standard specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. It is applicable to both hand-mixed and capsulated cements for mechanical mixing and 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 2 of this standard specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.
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FDA recognition of ANSI ADA Standard No. 96-2012 [Rec# 4-215] will be superseded by recognition of ANSI ADA Standard No. 96-2020 [Rec# 4-325].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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