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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 NumberS008
Date Received09/13/2002
Decision Date12/02/2003
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 Yes
Approval Order Statement 
Approval for the addition of the following indication for use: "endogain gel is indicated for use in coronally positioned flap procedures for the treatment of gingival recession defects". The device, with this additional indication for use, will be marketed under the trade name endogain gel.
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