LZD · Joint, Temporomandibular, Implant
Dental · 21 CFR 872.3940 · Class 3
Overview
| Product Code | LZD |
|---|---|
| Device Name | Joint, Temporomandibular, Implant |
| Regulation | 21 CFR 872.3940 |
| Device Class | Class 3 |
| Review Panel | Dental |
| Implant | Yes |
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P020016 | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | Sep 21, 2005 | APPR |
| P000023 | TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES | Nexus CMF, LLC | Jan 5, 2001 | APPR |
| P980052 | TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | TMJ Concepts | Jul 2, 1999 | APPR |
Top Applicants
- Biomet Microfixation, Inc. — 1 clearance
- Nexus CMF, LLC — 1 clearance
- TMJ Concepts — 1 clearance
