Oral-B 5% Sodium Fluoride Varnish
FDA 510(k) clearance K153334 · decided 2016-05-20
Clearance details
- K-number
- K153334
- Device name
- Oral-B 5% Sodium Fluoride Varnish
- Applicant
- Young Dental Manufacturing Co. 1, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-11-19
- Decision date
- 2016-05-20
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Earth City, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish recall (Z-1697-2023) | Young Dental Manufacturing I, LLC | 2023-06-08 |