K953526 is an FDA 510(k) clearance for the SEEK. This device is classified as a Device, Caries Detection (Class II - Special Controls, product code LFC).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 5, 1995, 40 days after receiving the submission on July 27, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1740.
| 510(k) Number | K953526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1995 |
| Decision Date | September 05, 1995 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LFC — Device, Caries Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1740 |