K241041 is an FDA 510(k) clearance for the Silver Fluoride Hypersensitivity Varnish. This device is classified as a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II - Special Controls, product code PHR).
Submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on February 28, 2025, 318 days after receiving the submission on April 16, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260. Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity..
| 510(k) Number | K241041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2024 |
| Decision Date | February 28, 2025 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PHR - Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |
| Definition | Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity. |