K100172 is an FDA 510(k) clearance for the TOKUYAMA SHIELD FORCE. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Tokuyama Dental Corporation (Washington, US). The FDA issued a Cleared decision on October 21, 2010, 273 days after receiving the submission on January 21, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K100172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2010 |
| Decision Date | October 21, 2010 |
| Days to Decision | 273 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 |