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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceTotal Temporomandibular Joint Replacement System
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
1520 tradeport dr.
jacksonville, FL 32218
PMA NumberP020016
Supplement NumberS011
Date Received11/18/2019
Decision Date12/17/2019
Product Code LZD 
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of updates to the Prints, Inspection Overlays, and Machine program headers of the TMJ Fossa Components.