|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 Name||biologic material, dental|
|Generic Name||enamel derivative|
|Supplement Type||real-time process|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to change from the emdogain(r) two vial system to the emogain(r) gel filled sterile syringes.