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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 063 Date of Entry 12/23/2024 
FR Recognition Number 4-330
Standard
ANSI ADA  Standard No. 63-2020
Endodontic Instruments - Auxillary
Scope/Abstract
This standard specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures not cited in ANSI/ADA Standard Nos. 28, 71, 95 or 101. It also specifies requirements for size, product designation, safety considerations, instructions and labeling.

This standard is a modified adoption of ISO 3630-4:2009 Dentistry - Root canal instruments - Part 4: Auxiliary 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FDA recognition of ANSI ADA Standard No. 63-2013 [Rec# 4-272] will be superseded by recognition of ANSI ADA Standard No. 63-2020 [Rec# 4-330]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-272] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 4-272] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.4565 Broach, Endodontic Class 1 EKW
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 Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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