(168 days)
Simultaneous use of GBR-membrane (BIO-GIDE®) and implants; augmentation around implants placed in immediate extraction 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; guided bone regeneration in dehiscence defects; and guided tissue regeneration procedures in periodontal defects.
BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.
The provided text does not contain information about acceptance criteria or a study demonstrating device performance against such criteria. The document is a 510(k) summary for the BIO-GIDE® resorbable bilayer membrane, which focuses on demonstrating substantial equivalence to previously cleared predicate devices (K960724 and K042197).
The key point of this 510(k) summary is the addition of a heating step (70℃ for at least 30 minutes) to the manufacturing process for assurance that organisms causing Transmissible Spongiform Encephalopathies Disease have been destroyed. The document explicitly states: "The revised manufacturing process has been validated and tests have been done that confirm that the additional heating step does not affect the final product and that, as such, there were no changes that would render the product not substantially equivalent to the previously cleared predicate product."
Therefore, the requested information cannot be extracted from this document, as it does not describe a study proving the device meets specific performance acceptance criteria. It focuses on validating a manufacturing process change and demonstrating substantial equivalence.
§ 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.