K260830 is an FDA 510(k) clearance for the APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste). 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 March 18, 2026, 5 days after receiving the submission on March 13, 2026.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K260830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2026 |
| Decision Date | March 18, 2026 |
| Days to Decision | 5 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 |