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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 4-206: ISO 14457 First edition 2012-09-15, dentistry - handpieces and motors. (Dental/ENT)

Date of Standard: 2012. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Air powered handpieces
Straight and geared angle handpieces
Low voltage electric motors used with handpieces
Dental Operative Units
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulations
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.4120 Handpiece, Rotary Bone Cutting Class 2 KMW
§872.4200 Controller, Foot, Handpiece And Cord Class 1 EBW
§872.4200 Handpiece, Air-Powered, Dental Class 1 EFB
§872.4200 Handpiece, Air-Powered, Root Canal Irrigation Class 1 NYL
§872.4200 Handpiece, Belt And/Or Gear Driven, Dental Class 1 EFA
§872.4200 Handpiece, Contra- And Right-Angle Attachment, Dental Class 1 EGS
§872.4200 Handpiece, Direct Drive, Ac-Powered Class 1 EKX
§872.4200 Handpiece, Water-Powered Class 1 EKY
§872.6640 Unit, Operative Dental Class 1 EIA
Relevant Guidance:
Guidance for Industry and FDA Staff Dental Handpieces - Premarket Notification [510(k)] Submissions Document issued on: May 2, 2007
FDA Technical Contacts:
 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
 Lauren Giles
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2546
  Silver Spring MD 20993
  301/796-9552
  email: lauren.giles@fda.hhs.gov
 Michael Mendelson
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2548
  Silver Spring MD 20993
  301/796-6280
  email: michael.mendelson@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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