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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 056 Date of Entry 06/07/2021 
FR Recognition Number 4-278
Standard
ISO  4823 Fifth edition 2021-02
Dentistry - Elastomeric impression and bite registration materials
Identical Adoption
ANSI ADA Standard No. 19-2022
Elastomeric Impression and Bite Registration
Scope/Abstract
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.
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FDA recognition of ISO 4823 Fifth edition 2021-02 [Rec# 4-278] will be superseded by recognition of ISO 4823 Sixth edition 2025-06 [Rec# 4-368]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-278] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 4-278] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3660 Material, Impression Class 2 ELW
Relevant FDA Guidance and/or Supportive Publications*
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
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  Joel.Anderson@fda.hhs.gov
 Ran Huo
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  240-402-6705
  Ran.Huo@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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