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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 061 Date of Entry 12/18/2023 
FR Recognition Number 4-310
Standard
ISO  22112 Second edition 2017-08
Dentistry - Artificial teeth for dental prostheses
Identical Adoption
ANSI ADA Standard No. 15-2021
Artificial Teeth for Dental Prostheses
Scope/Abstract
ISO 22112:2017 specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.
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FDA recognition of ISO 22112 First edition 2005-11 [Rec# 4-151] will be superseded by recognition of ISO 22112 Second edition 2017-08 [Rec# 4-310]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-151] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-151] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3590 Denture, Plastic, Teeth Class 2 ELM
§872.3590 Additively Manufactured, Preformed, Resin Denture Tooth Class 2 PZY
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
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 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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