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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.
 
Trade NameEMODOGAIN
Classification Namebiologic material, dental
Generic Nameenamel derivative
Regulation Number872.3930
ApplicantTHE STRAUMANN CO.
PMA NumberP930021
Supplement NumberS010
Date Received11/16/2007
Decision Date11/28/2007
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two modifications to the device instructions for use: 1) a modification of the description of emodogain, and 2) a restriction of the recommendation to the use of prefgel tooth conditioner.
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