(700 days)
Ostim is intended as a filling or reconstruction material for repair of bony defects in oral, gnathic and facial applications in the following indications:
- Filling of intraoral bony defects such as those resulting from cytectomies, tooth tip I resections, extractions or surgical tooth removal.
- Augmentations in the area of the alveolar processes and maxillary sinuses.
- Filling of periodontal defects.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or the other specific points requested in your prompt. The document is a 510(k) clearance letter from the FDA for a bone grafting material called Ostim®, outlining its regulatory status and intended use, but it does not include a scientific study or performance data table.
§ 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.