K222891 is an FDA 510(k) clearance for the Dental Desensitizer. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Guangzhou Beogene Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 25, 2023, 244 days after receiving the submission on September 23, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K222891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2022 |
| Decision Date | May 25, 2023 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LBH - Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |