K123653 is an FDA 510(k) clearance for the SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED). 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 June 3, 2013, 188 days after receiving the submission on November 27, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K123653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2012 |
| Decision Date | June 03, 2013 |
| Days to Decision | 188 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 |