K182917 is an FDA 510(k) clearance for the FluoroCal. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on November 18, 2019, 395 days after receiving the submission on October 19, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K182917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2018 |
| Decision Date | November 18, 2019 |
| Days to Decision | 395 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 |