K221194 is an FDA 510(k) clearance for the LEDEX. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Dentmate Technology Co. , Ltd. (New Taipei, TW). The FDA issued a Cleared decision on September 16, 2022, 144 days after receiving the submission on April 25, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K221194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2022 |
| Decision Date | September 16, 2022 |
| Days to Decision | 144 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 |