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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 4-265
Standard
ISO 10271 Third edition 2020-08
Dentistry - Corrosion test methods for metallic materials
U.S. Identical Adoption
ANSI ADA Standard No. 97-2020
Corrosion Test Methods for Metallic Materials
Scope/Abstract
This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials.

This document is not applicable to dental instruments.
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FDA recognition of ISO 10271 Second edition 2011-08-01 [Rec# 4-245] will be superseded by recognition of ISO 10271 Third edition 2020-08 [Rec# 4-265]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-245] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 4-245] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
Relevant FDA Guidance and/or Supportive Publications*
1. Class II Special Controls Guidance Document: Dental Noble Metal Alloys - Guidance for Industry and FDA Staff, Issued August 2004.

2. Class II Special Controls Guidance Document: Dental Base Metal Alloys - Guidance for Industry and FDA Staff, Issued August 2004.
FDA Technical Contacts
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
 Lauren Giles
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-9552
  lauren.giles@fda.hhs.gov
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  joel.anderson@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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