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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 063 Date of Entry 12/23/2024 
FR Recognition Number 4-332
Standard
ADA ANSI  Standard No. 206-2024
Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File
Scope/Abstract
This standard applies to implantable materials used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (>90 %) hydroxyapatite are not covered by this standard.

Evaluation includes the physico-chemical, mechanical, biological, and clinical aspects and behavior of these implantable dental materials.

Materials such as autografts, allografts, human sourced bone filling materials, barrier membranes, and products for which the intended use is to deliver a medicinal and/or biological product are not covered by this standard.
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 Bone Grafting Material, Synthetic Class 2 LYC
§872.3930 Bone Grafting Material, Animal Source Class 2 NPM
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.

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
 Joel Anderson
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6520
  Joel.Anderson@fda.hhs.gov
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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