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 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.
| Device | PERI-OSS |
| Generic Name | Implant, Endosseous, Root-form |
| Applicant | CURASAN AG |
| Date Received | 2001-06-25 |
| Decision Date | 2001-10-04 |
| PMA | P800035 |
| Supplement | S010 |
| Product Code | DZE |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |