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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 4-96: ADA / ANSI ADA Specification No.30:2000 (Reaffirmed 2005), dental zinc oxide-eugenol and zinc oxide non-eugenol cements. (Dental/ENT)

Date of Standard: 2000. 
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:
Dental cements
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes. Products do not have to meet the performance requirements in order to conform to the test methods listed in the 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
§872.3275 Cement, Dental Class 2 EMA
Relevant Guidance:
Guidance for Industry and FDA Staff Dental Cements - Premarket Notification Document issued on: August 18, 1998
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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