K222323 is an FDA 510(k) clearance for the Black Diamond. This device is classified as a Diammine Silver Fluoride Dental Hypersensitivity Varnish (Class II - Special Controls, product code PHR).
Submitted by Elevate Oral Care, LLC (West Palm Beach, US). The FDA issued a Cleared decision on June 23, 2023, 325 days after receiving the submission on August 2, 2022.
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 | K222323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2022 |
| Decision Date | June 23, 2023 |
| Days to Decision | 325 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. |