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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBIORA EMDOGAIN(R)
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantTHE STRAUMANN COMPANY
60 Minuteman Road
Andover, MA 01810
PMA NumberP930021
Date Received07/19/1993
Decision Date09/30/1996
Product Code NQA 
Docket Number 96M-0482
Notice Date 11/21/1996
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE EMDOGAIN
Supplements:  S002 S003 S004 S006 S007 S008 S001 S011 S010 S005 S013 
S015 S014 S009 S012 S016 S017 S024 S026 S029 S031 S020 S019 
S018 S021 S022 S023 S025 S032 S030 S027 S028 
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