K143575 is an FDA 510(k) clearance for the Accu-Dent XD Tray, Accu-Dent XD Syringe. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on April 3, 2015, 107 days after receiving the submission on December 17, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K143575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2014 |
| Decision Date | April 03, 2015 |
| Days to Decision | 107 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |