K101504 is an FDA 510(k) clearance for the TI-CORE FLOW. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on October 29, 2010, 150 days after receiving the submission on June 1, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K101504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2010 |
| Decision Date | October 29, 2010 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |