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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 NameEMDOGAIN
Classification Namebiologic material, dental
Generic Nameenamel derivative
Regulation Number872.3930
ApplicantTHE STRAUMANN CO.
PMA NumberP930021
Supplement NumberS009
Date Received04/11/2006
Decision Date04/24/2006
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of post-market experience information to the warning section of the emdogain package insert.
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