K250009 is an FDA 510(k) clearance for the LED Curing Light (C01-X, C02-X). This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Premium Plus (Dongguan) Limited (Dongguan, CN). The FDA issued a Cleared decision on April 10, 2025, 98 days after receiving the submission on January 2, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K250009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2025 |
| Decision Date | April 10, 2025 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| 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 |