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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Classification Namejoint, temporomandibular, implant
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
Applicant
TMJ CONCEPTS
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 
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