|
Device | TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS |
Generic Name | joint, temporomandibular, implant |
Regulation Number | 872.3940 |
Applicant |
TMJ CONCEPTS |
2233 knoll drive |
ventura, CA 93003 |
|
PMA Number | P980052 |
Date Received | 01/06/1999 |
Decision Date | 07/02/1999 |
Product Code |
LZD
|
Docket Number | 99M-2551 |
Notice Date | 08/02/1999 |
Advisory Committee |
Dental |
Expedited Review Granted? | No |
Combination Product |
No
|
Recalls |
CDRH Recalls
|
Approval Order Statement
Approval for the TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis. The device is indicated for reconstruction of the temporomandibular joint. Patients should be considered if they have one or more of the following conditions: 1) Inflammaotry arthritis involving the temporomandibular joint not responsive to other modalities of treatment; 2) Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; 3) Failed tissue graft; 4) Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S004 S008 S007 S005 |