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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceStraumann Emdogain
Generic NameBiologic material, dental
Regulation Number872.3930
ApplicantThe Straumann Company
60 Minuteman Rd.
Andover, MA 01810
PMA NumberP930021
Supplement NumberS031
Date Received03/23/2023
Decision Date04/18/2023
Product Code NQA 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of a new washer disinfector for production.
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