K240059 is an FDA 510(k) clearance for the FAgamin®. This device is classified as a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II - Special Controls, product code PHR).
Submitted by Tedequim Srl (Córdoba, AR). The FDA issued a Cleared decision on May 16, 2024, 129 days after receiving the submission on January 8, 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 | K240059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2024 |
| Decision Date | May 16, 2024 |
| Days to Decision | 129 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. |