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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 060 Date of Entry 05/29/2023 
FR Recognition Number 4-301
Standard
ISO  21563 Second edition 2021-08
Dentistry - Hydrocolloid impression materials
U.S. Identical Adoption
ANSI ADA Standard No. 128-2022
Hydrocolloid Impression Materials
Scope/Abstract
This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. 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FDA recognition of ISO 21563 First edition 2013-08 [Rec# 4-240] will be superseded by recognition of ISO 21563 Second edition 2021-08 [Rec# 4-301]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-240] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-240] 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
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
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
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@fda.hhs.gov
 Ran Huo
  FDA/OMPT/CDRH/OPEQ/OHT1/DHT1B
  --
  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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