(595 days)
Augmentation or reconstructive treatment of alveolar ridge defects also of any indeasal defects Filling of periodontal defects Filling of defects after root resection, apicoectony, and cyscecomy, and cyscecomy of the also and of and and and and enhance preservarion of- the alveola Filling of defects after root teseccion, approactory, and of the alvestar ridge Elevacion of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Filling of periodontal defects in conjunector aren production (GBR). Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). villag of peri-implant defects in conjunction with products intended for the before Bear archier/GRP) Guided Bone Regeneration (GBR)
Anorganic Bovine Bone
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a medical device (Bio-Oss Anorganic Bovine Bone) and discusses its substantial equivalence to a predicate device for marketing purposes. It does not include acceptance criteria, study details, performance metrics, sample sizes, or information about ground truth establishment.
§ 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.