|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||normal 180 day track|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for packaging changes for emdogain(r). The following packaging changes are now approved: 1) a change in the size of the glass vial in which the emdogain powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.