CERASORB DENTAL
FDA premarket approval P800035/S011 · decided 2003-12-08
Approval details
- PMA number
- P800035
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CERASORB DENTAL
- Generic name
- Bone grafting material, for dental bone repair
- Applicant
- Curasan AG
- Date received
- 2002-04-05
- Decision date
- 2003-12-08
- Days to decision
- 612 days
- Decision code
- APPR
- Product code
- LPK
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Dkeinostheim
- Statement
- 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 ALVE
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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 |