TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Joint, Temporomandibular, Implant

FDA Premarket Approval P980052

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.

Pre-market Approval Supplement Details

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.

DeviceTMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Classification NameJoint, Temporomandibular, Implant
Generic NameJoint, Temporomandibular, Implant
ApplicantTMJ CONCEPTS
Date Received1999-01-06
Decision Date1999-07-02
Notice Date1999-08-02
PMAP980052
SupplementS
Product CodeLZD
Docket Number99M-2551
Advisory CommitteeDental
Expedited ReviewNo
Combination Product No
Applicant Address TMJ CONCEPTS 2233 Knoll Drive ventura, CA 93003
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P980052Original Filing
S011 2022-08-22 30-day Notice
S010
S009 2020-12-11 Normal 180 Day Track No User Fee
S008 2020-10-27 30-day Notice
S007 2019-07-11 Normal 180 Day Track No User Fee
S006
S005 2012-07-10 Normal 180 Day Track No User Fee
S004 2009-03-03 Normal 180 Day Track No User Fee
S003
S002 2002-11-27 Normal 180 Day Track
S001 2002-01-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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