(475 days)
BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants: augmentation around implants placed in immediate extract sockets; - augmentation around implants placed in delayed extraction sockets; . - . localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment - filling of bone defects after root resection, cystectomy, removal of retained teeth. Becayse of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)
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§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.