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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 GEL
Classification Namebiologic material, dental
Generic Nameenamel derivative
Regulation Number872.3930
ApplicantBIORA, INC.
PMA NumberP930021
Supplement NumberS006
Date Received06/17/2002
Decision Date03/28/2003
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extension of the expiration date on emdogain gel from 18 months to 24 months.
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