PERI-OSS
FDA premarket approval P800035 · decided 1981-03-24
Approval details
- PMA number
- P800035
- Trade name
- PERI-OSS
- Generic name
- Bone grafting material, for dental bone repair
- Applicant
- Curasan AG
- Date received
- 1980-06-12
- Decision date
- 1981-03-24
- Days to decision
- 285 days
- Decision code
- APRL
- Product code
- LPK
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Dkeinostheim
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceracell Ortho Foam (K181721) | Curasan AG | 2018-09-17 |
| Cerasorb Ortho Foam (K160566) | Curasan AG | 2016-12-02 |
| CURASAN OSSEOLIVE DENTAL (K111105) | Curasan AG | 2012-12-20 |
| CERACELL DENTAL (K103709) | Curasan AG | 2011-03-10 |
| OSBONE DENTAL (K102872) | Curasan AG | 2011-01-12 |
| BONEOPTIMIZER (K100841) | Curasan AG | 2010-08-19 |
| REVOIS IMPLANT SYSTEM (K063106) | Curasan AG | 2007-06-11 |
| CERASORB M ORTHO (K040216) | Curasan AG | 2004-03-26 |