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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 4-145: ISO 22803 First edition 2004-09-01, dentistry - membrane materials for guided tissue regeneration in oral and maxillofacial surgery - contents of a technical file. (Dental/ENT)

Date of Standard: 2004. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Barrier Membranes
Processes Affected:
510(k), PMA, IDE, HDE, PDP
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3930 Barrier, Synthetic, Intraoral Class 2 NPK
Relevant Guidance:
Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices Document issued on: April 28, 2005
FDA Technical Contact:
 Robert Betz
  FDA/CDRH/ODE
  9200 CORPORATE BLVD., HFZ-480
  ROCKVILLE MD 20850
  240/276-3702
  email: robert.betz@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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