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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.
 
Trade NameTMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Classification Namejoint, temporomandibular, implant
Generic Nametotal temporomandibular joint prosthesis
Regulation Number872.3940
ApplicantTMJ CONCEPTS
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S004 
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