Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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063
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Date of Entry 12/23/2024
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FR Recognition Number
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4-332
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Standard | |
ADA ANSI Standard No. 206-2024 Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File |
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Scope/AbstractThis 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.
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3930 |
Bone Grafting Material, Synthetic
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Class 2
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LYC
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§872.3930 |
Bone Grafting Material, Animal Source
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Class 2
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NPM
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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. |
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FDA Technical Contacts
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |