(57 days)
REGEN BIOCEMENT is intended to be used as a bone grafting material in the maxillofacial region.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "REGEN BIOCEMENT," indicated for use as a bone grafting material in the maxillofacial region.
This document does not contain any information regarding:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test or training sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Types of ground truth used.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed study results on the device's performance against specific acceptance criteria. The letter confirms that the FDA has determined the device is substantially equivalent to a predicate, allowing it to be marketed.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.