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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 ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115
Classification Namebiologic material, dental
Generic Nameenamel derivative
Regulation Number872.3930
PMA NumberP930021
Supplement NumberS013
Date Received09/19/2012
Decision Date07/02/2013
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at medeon science park, malmo, sweden.