(211 days)
As an aid in sinus augmentation (sinus lift) procedures.
As an aid in the augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects.
As an aid in the treatment of periapical and periodontal defects.
Not Found
I apologize, but the provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the OsteoGen® (SBRG) device, indicating that it has been found substantially equivalent to a legally marketed predicate device.
The content focuses on regulatory information, the device's indications for use, and contact details for the FDA. There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
Therefore, I cannot fulfill your request based on the input provided.
§ 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.