SINCLAIR ORAL RINSE
FDA 510(k) clearance K053166 · decided 2006-05-17
Clearance details
- K-number
- K053166
- Device name
- SINCLAIR ORAL RINSE
- Applicant
- Sinclair Pharmaceuticals Limited
- Decision
- Substantially Equivalent
- Date received
- 2005-11-14
- Decision date
- 2006-05-17
- Days to decision
- 184 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| DECAPINOL ORAL RINSE (DEN050001) | Sinclair Pharmaceuticals Limited | 2005-04-18 |
Recalls involving this device
No recalls on record reference this clearance.