(422 days)
A-Oss® is applicable in filling of the bone defect and bone augmentation in the following dental areas.
- Filling in the missing part of a bone due to periodontal disease, cystectomy, or dental extraction
- Filling in the missing part of a bone surrounding an implant
- Maxillary sinus lift for implant
- Alveolar bone augmentation/restoration
Bone Grafting Material
The provided text is a 510(k) premarket notification letter from the FDA to Hiossen Inc. regarding their device, A-Oss®. It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria, device performance testing, or study details.
Therefore, I cannot extract the requested information regarding design verification, validation, and performance studies. The document primarily focuses on regulatory approval and compliance.
§ 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.