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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Entry 09/09/2008 
FR Recognition Number 4-145
Standard
ISO  22803 First edition 2004-09-01
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
Scope/Abstract
This International Standard gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used
- for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,
- in contact with teeth and/or dental implants,
- for prevention of epithelial migration in periodontal surgery,
- for the augmentation of bone prior to the planned insertion of dental implants,
- and/or for augmentation of bone for stabilization of dental prostheses.

This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3930 Barrier, Synthetic, Intraoral Class 2 NPK
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices Document issued on: April 28, 2005

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Andrew Steen
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6284
  Andrew.Steen@fda.hhs.gov
 Lo Linh
  FDA/OC/CDRH/OPEQ/RPGS/
  301-796-0463
  Linh.Lo@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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