K240619 is an FDA 510(k) clearance for the e-SDF. This device is classified as a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II - Special Controls, product code PHR).
Submitted by Kids-E-Dental Llp (Mumbai, IN). The FDA issued a Cleared decision on March 6, 2024, 1 day after receiving the submission on March 5, 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 | K240619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2024 |
| Decision Date | March 06, 2024 |
| Days to Decision | 1 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. |