K150218 is an FDA 510(k) clearance for the Fill-Up!. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Coltene/Whaledent AG (Altstätten, CH). The FDA issued a Cleared decision on June 23, 2015, 144 days after receiving the submission on January 30, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K150218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2015 |
| Decision Date | June 23, 2015 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |