K953168 is an FDA 510(k) clearance for the ULTRACID F DISINFECTING SOLUTION. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 8, 1995, 63 days after receiving the submission on July 7, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K953168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1995 |
| Decision Date | September 08, 1995 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |