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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 4-304
Standard
ISO  21606 Second edition 2022-08
Dentistry - Elastomeric auxiliaries for use in orthodontics
Scope/Abstract
This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.
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FDA recognition of ISO 21606 First edition 2007-06 [Rec# 4-267] will be superseded by recognition of ISO 21606 Second edition 2022-08 [Rec# 4-304]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-267] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 4-267] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.5410 Band, Elastic, Orthodontic Class 1 ECI
§872.5500 Headgear, Extraoral, Orthodontic Class 2 DZB
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 Contact
 Bobak Shirmohammadi
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-3639
  Bobak.Shirmohammadi@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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