K100290 is an FDA 510(k) clearance for the ESTEMP NE. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on February 17, 2010, 15 days after receiving the submission on February 2, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K100290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2010 |
| Decision Date | February 17, 2010 |
| Days to Decision | 15 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 |