ADA206-2024D
ANSI/ADA Standard No. 206 for Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File
Learn about the rigorous evaluation criteria for implantable dental materials, encompassing physico-chemical, mechanical, biological, and clinical aspects, as outlined in ANSI/ADA Standard No. 206.
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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.
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