|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||implant, endosseous, root-form|
|Generic Name||calcium phosphate-ceramic|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new trade name. The device, as modified, will be marketed under the trade name, peri-oss and is indicated for repair of periodontal and periapical bony defects.