21 CFR 872.3940 — Joint, Temporomandibular, Implant
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3940
Identification
A total temporomandibular joint prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LZD | Joint, Temporomandibular, Implant | 3 | 3 | Implant |
