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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.
DevicePatient-Fitted TMJ Reconstruction Prosthesis System
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
PMA NumberP980052
Supplement NumberS009
Date Received12/11/2020
Decision Date04/27/2021
Product Code LZD 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for heat treatment of surgical instruments by Solar Atmospheres, located at 8606 Live Oak Ave Fontana, CA.