DECAPINOL ORAL RINSE
FDA 510(k) clearance DEN050001 · decided 2005-04-18
Clearance details
- K-number
- DEN050001
- Device name
- DECAPINOL ORAL RINSE
- Applicant
- Sinclair Pharmaceuticals Limited
- Decision
- Unknown
- Date received
- 2005-01-24
- Decision date
- 2005-04-18
- Days to decision
- 84 days
- Clearance type
- Post-NSE
- Product code
- NTO
- Device class
- 2
- Regulation number
- 872.5580
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Godalming, Surrey, GB
- 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.
| Record | Firm | Date |
|---|---|---|
| SINCLAIR ORAL RINSE (K053166) | Sinclair Pharmaceuticals Limited | 2006-05-17 |
Recalls involving this device
No recalls on record reference this clearance.