(126 days)
Synthograft is designed for:
- the filling and or reconstruction of either traumatic or degenerative multi-wall bone defects
- the augmentation of the sinus floor
- the augmentation of the alveolar ridges
- the augmentation of the alveblar hagos
- the filling of periodontal or other alveolar bone defects and tooth sockets and osteotomies
- the preservation of the alveolus for the preparation of an implant site.
Not Found
This document is a 510(k) substantial equivalence letter for a device named "Synthograft," a bone grafting material. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it is a regulatory clearance document rather than a performance study report.
Therefore, I cannot provide a response filling in the requested information as the source text does not contain such details. The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory conditions for marketing.
§ 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.