21 CFR 872.3950 — Glenoid Fossa Prosthesis
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3950
Identification
A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MPI | Glenoid Fossa Prosthesis | 3 | 1 | Implant |