Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

034

Date of Entry 01/30/2014

FR Recognition Number

4-151

Standard

ISO 22112 First edition 2005-11-01
Dentistry - Artificial teeth for dental prostheses

Identical Adoption

ANSI ADA Standard No. 15-2008 (R2013)
Artificial Teeth for Dental Prostheses

Scope/Abstract

ISO 22112:2005 specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry.

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FDA recognition of ISO 22112 First edition 2005-11 [Rec# 4-151] will be superseded by recognition of ISO 22112 Second edition 2017-08 [Rec# 4-310].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