CURASAN OSSEOLIVE DENTAL
FDA 510(k) clearance K111105 · decided 2012-12-20
Clearance details
- K-number
- K111105
- Device name
- CURASAN OSSEOLIVE DENTAL
- Applicant
- Curasan AG
- Decision
- Substantially Equivalent
- Date received
- 2011-04-20
- Decision date
- 2012-12-20
- Days to decision
- 610 days
- Clearance type
- Abbreviated
- Product code
- LYC
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Rome, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CERASORB DENTAL (P800035/S011) | Curasan AG | 2003-12-08 |
| PERI-OSS (P800035/S010) | Curasan AG | 2001-10-04 |
| SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S007) | Curasan AG | 1984-08-07 |
| AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG (P800035/S008) | Curasan AG | 1983-11-10 |
| SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S004) | Curasan AG | 1983-06-07 |
| SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S003) | Curasan AG | 1982-11-08 |
| SYNTHOGRAFT(TM) LARGE GRANULAR (LG) (P800035/S005) | Curasan AG | 1982-08-09 |
| SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S002) | Curasan AG | 1982-07-16 |