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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.
Classification Namebiologic material, dental
Generic Nameenamel derivative
Regulation Number872.3930
PMA NumberP930021
Supplement NumberS011
Date Received03/27/2008
Decision Date06/19/2009
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following: 1) the use of straumann emdogain with bone substitute material, such as straumann bone ceramic; 2) labeling changes to modify a statement regarding the long term stability of regenerated tissue; 3) labeling change to add additional surgical techniques for the treatment of gingival recession defects; 4) labeling change to include instructions in the ¿storage¿ section in instructions for use for homogenization if the material is separated in the syringe; and 5) clarify the instructions under each of the three clinical procedures in the instructions for use to better align them with one another.