OSSIX -PLUS
FDA 510(k) clearance K053260 · decided 2006-02-22
Clearance details
- K-number
- K053260
- Device name
- OSSIX -PLUS
- Applicant
- Colbar Lifescience , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-22
- Decision date
- 2006-02-22
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- NPL
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| EVOLENCE COLLAGEN FILLER (P070013/S003) | Colbar Lifescience , Ltd. | 2009-06-05 |
| EVOLENCE COLLAGEN FILLER (P070013/S005) | Colbar Lifescience , Ltd. | 2008-10-31 |
| EVOLENCE COLLAGEN FILLER (P070013/S002) | Colbar Lifescience , Ltd. | 2008-09-15 |
| EVOLENCE COLLAGEN DERMAL FILLER (P070013/S001) | Colbar Lifescience , Ltd. | 2008-08-14 |
| EVOLENCE COLLAGEN FILLER (P070013) | Colbar Lifescience , Ltd. | 2008-06-27 |