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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 4-202: ADA / ANSI Specification No.58 , root canal files, type h (hedstrom). (Dental/ENT)

Date of Standard: 2010. 
Addresses of Standards Development Organizations:
 American Dental Association (ADA)
  211 East Chicago Avenue
  Chicago, IL 60611-2678
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Root Canal Files
Processes Affected:
510(k), PMA, IDE, HDE, PDP, Design Control Input, Quality System Regulation
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard.

Data from the test methods in the standard is needed. Additional testing may be necessary for some products.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.4565 File, Pulp Canal, Endodontic Class 1 EKS
FDA Technical Contact:
 Leah Royce
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G460
  Silver Spring MD 20993
  301/796-6268
  email: leah.royce@fda.hhs.gov
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