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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 NameSTRAUMANN EMDOGAIN
Classification Namebiologic material, dental
Generic Nameenamel derivative
Regulation Number872.3930
ApplicantTHE STRAUMANN CO.
PMA NumberP930021
Supplement NumberS012
Date Received01/12/2009
Decision Date08/21/2009
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at iba sterigenics wallonie, s. A. , in verviers, belgium, for the contract sterilization of the device.
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