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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 NumberS007
Date Received07/01/2002
Decision Date05/20/2003
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the additional indications for use as an adjunct to periodontal surgery for mandibular class ii furcations with minimal interproximal bone loss.
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