K043119 is an FDA 510(k) clearance for the AMELOGEN PLUS. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 17, 2004, 37 days after receiving the submission on November 10, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K043119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2004 |
| Decision Date | December 17, 2004 |
| Days to Decision | 37 days |
| Submission Type | Special |
| 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 |