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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
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FDA recognition of ISO 4823 Fourth edition 2015-08 [Rec# 4-225] will be superseded by recognition of ISO 4823 Fifth edition 2021-02 [Rec# 4-278]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-225] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 4-225] 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
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
 Michelle Chavis
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  --
  Michelle.Chavis@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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