This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for design changes, a trade name change, and new manufacturing sites. This approval also acknowledges that ownership has been transferred from miter, inc. To curasan ag. Cerasorb dental will be manufactured at two new facilities located at curasan ag, germany and willy rusch ag, germany. The device, as modified, will be marketed under the trade name cerasorb dental and is indicated for defects after extirpation of dental alveolar cysts; repair of marginal and periapical periodontal alveolar bony pockets as well as bifurcations and trifurcations of the teeth; augmentation of the atrophied alveolar ridge; alveolar augmentation of mandibular and maxillary ridges; defects after apicoectomy; and filling bone defects after surgical resection of impacted teeth (without implantation).
| Device | CERASORB DENTAL |
| Generic Name | Bone Grafting Material, For Dental Bone Repair |
| Applicant | CURASAN AG |
| Date Received | 2002-04-05 |
| Decision Date | 2003-12-08 |
| PMA | P800035 |
| Supplement | S011 |
| Product Code | LPK |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CURASAN AG lindigstrasse 4 kleinostheim D-638-6380 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800035 | Original Filing | |
| S011 | 2002-04-05 | Normal 180 Day Track |
| S010 | 2001-06-25 | Normal 180 Day Track |
| S009 | ||
| S008 | 1983-10-11 | |
| S007 | 1983-09-13 | |
| S006 | ||
| S005 | 1982-06-15 | |
| S004 | 1982-12-20 | |
| S003 | 1982-10-22 | |
| S002 | 1982-06-30 | |
| S001 | 1981-12-14 |