K060334 is an FDA 510(k) clearance for the GI DENTSTAT. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 23, 2006, 14 days after receiving the submission on February 9, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K060334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2006 |
| Decision Date | February 23, 2006 |
| Days to Decision | 14 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |