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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
ApplicantBIORA, INC.
PMA NumberP930021
Supplement NumberS004
Date Received03/09/2000
Decision Date01/19/2001
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typereal-time process
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change from the emdogain(r) two vial system to the emogain(r) gel filled sterile syringes.
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