K220419 is an FDA 510(k) clearance for the Apapro Desensitizer. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Sangi Co, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on February 16, 2022, 2 days after receiving the submission on February 14, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K220419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2022 |
| Decision Date | February 16, 2022 |
| Days to Decision | 2 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 |