K243777 is an FDA 510(k) clearance for the Rennou™ Varnish (3% / Spearmint). This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Theodent, LLC (New Orleans, US). The FDA issued a Cleared decision on May 27, 2025, 169 days after receiving the submission on December 9, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K243777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2024 |
| Decision Date | May 27, 2025 |
| Days to Decision | 169 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 |