SYNTHOGRAFT(TM) LARGE GRANULAR (LG)
FDA premarket approval P800035/S005 · decided 1982-08-09
Approval details
- PMA number
- P800035
- Supplement
- S005
- Trade name
- SYNTHOGRAFT(TM) LARGE GRANULAR (LG)
- Generic name
- Implant, endosseous, root-form
- Applicant
- Curasan AG
- Date received
- 1982-06-15
- Decision date
- 1982-08-09
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- DZE
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Dkeinostheim
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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 |