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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
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantTMJ CONCEPTS
2233 KNOLL DRIVE
VENTURA, CA 93003
PMA NumberP980052
Date Received01/06/1999
Decision Date07/02/1999
Product Code LZD 
Docket Number 99M-2551
Notice Date 08/02/1999
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S005 S004 S001 S002 S007 S008 S009 S011 S012 
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