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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 4-201: ISO 9693-1 First edition 2012-02-15, dentistry -- compatibility testing - part 1: metal-ceramic systems. (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:
Base metal alloys, gold based alloys and preious metal alloys for clinical use, porcelain teeth, porcelain powder for clinical use, endosseous implant for prosthetic attachmenet
Processes Affected:
510(k), IDE, PMA, PDP, HDE, Quality System Regulation
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3920 Teeth, Porcelain Class 2 ELL
§872.6660 Powder, Porcelain Class 2 EIH
Relevant Guidance:
Guidance for Industry and FDA Staff Class II Special Controls
Guidance Document: Dental Nobel Metal Alloys Document issued on: August 23, 2004

Guidance for Industry and FDA Staff Class II Special Controls Guidance Document:
Dental Base Metal Alloys Document issued on: August 23, 2004

Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments Document issued on: May 12, 2004
FDA Technical Contacts:
 Michael Adjodha
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2606
  Silver Spring MD 20993
  301/796-6276
  email: michael.adjodha@fda.hhs.gov
 Andrew Steen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2604
  Silver Spring MD 20993
  301/796-6284
  email: andrew.steen@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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