K161353 is an FDA 510(k) clearance for the ESTELITE BULK FILL Flow. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 3, 2017, 322 days after receiving the submission on May 16, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K161353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2016 |
| Decision Date | April 03, 2017 |
| Days to Decision | 322 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 |