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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namejoint, temporomandibular, implant
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
2233 knoll drive
ventura, CA 93003
PMA NumberP980052
Date Received01/06/1999
Decision Date07/02/1999
Product Code
LZD[ Registered Establishments with LZD ]
Docket Number 99M-2551
Notice Date 08/02/1999
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
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 StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004