PERI-OSS
FDA premarket approval P800035/S010 · decided 2001-10-04
Approval details
- PMA number
- P800035
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERI-OSS
- Generic name
- Implant, endosseous, root-form
- Applicant
- Curasan AG
- Date received
- 2001-06-25
- Decision date
- 2001-10-04
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- DZE
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Dkeinostheim
- 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.
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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 |