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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 025 Publication Date: 10/04/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 4-86: ADA / ANSI ADA Specification No.38 2000 (Reaffirmed 2010), Metal-Ceramic Dental Restorative Systems. (Dental/ENT)

Date of Standard: 2010. 
Addresses of Standards 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:
Base metal alloys, gold based alloys and precious metal alloys for clinical use, porcelain teeth, porcelain powder for clinical use, endosseous implant for prosthetic attachment
Processes Affected:
510(k), PMA, IDE, HDE, PDP, Quality System Regulation
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard and any annexes. Data from the tests 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
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§872.3710 Alloy, Metal, Base Class 2 EJH
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§872.3920 Teeth, Porcelain Class 2 ELL
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§872.6660 Powder, Porcelain Class 2 EIH
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  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
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