K121093 is an FDA 510(k) clearance for the D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Dxm Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on November 27, 2012, 231 days after receiving the submission on April 10, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K121093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2012 |
| Decision Date | November 27, 2012 |
| Days to Decision | 231 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBZ - Activator, Ultraviolet, For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |