21 CFR 872.3960 — Mandibular Condyle Prosthesis
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3960
Identification
A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MPL | Mandibular Condyle Prosthesis | 3 | 0 | Implant |
