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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 043 Date of Entry 06/27/2016 
FR Recognition Number 4-202
Standard
ANSI ADA  Standard No. 58-2010 (R2015)
Root Canal Files, Type H (Hedstrom)
Scope/Abstract
This standard is for endodontic Hedstrom files for hand use only having a working part taper of 2% (0.02 millimeter per millimeter of length) as used in endodontic preparation or shaping operations.
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 File, Pulp Canal, Endodontic Class 1 EKS
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 Contact
 Phillip Woods
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6282
  phillip.woods@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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