(1294 days)
Augmentation of reconstructive treatment of the alveolar ridge
Filling of defects after root resection, apicoeccomy and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for Bio-Oss® Blocks. It confirms that the device is substantially equivalent to a legally marketed predicate device. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details about a study to prove the device meets acceptance criteria.
The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.
§ 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.