K110428 is an FDA 510(k) clearance for the ESCOM 100. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on February 25, 2011, 11 days after receiving the submission on February 14, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K110428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2011 |
| Decision Date | February 25, 2011 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |