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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
PMA NumberP020016
Supplement NumberS004
Date Received12/11/2009
Decision Date01/29/2010
Product Code
LZD[ Registered Establishments with LZD ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the packaging materials of both the fossa and the mandibular tmj system components, and extension of the shelf life of these devices to 5 years.