K120768 is an FDA 510(k) clearance for the ES FLOW. 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 May 3, 2012, 50 days after receiving the submission on March 14, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K120768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2012 |
| Decision Date | May 03, 2012 |
| Days to Decision | 50 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 |