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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 065 Date of Entry 12/22/2025 
FR Recognition Number 4-358
Standard
ANSI ADA  Standard No. 95-2020
Endodontics Instruments - Enlargers
Scope/Abstract
This standard specifies requirements for enlargers not cited in ANSI/ADA Standard No. 28, ANSI/ADA Standard No. 63, ANSI/ADA Standard No. 71, or ANSI/ADA Standard No. 101. This standard specifies requirements for size, marking, product designation, safety designation, safety considerations, and their labeling and packaging.

This is a modified version of ISO 3630-2 Fourth edition 2023-02 Dentistry-Endodontic instruments-Part 2: Enlargers.
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.
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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