K223507 is an FDA 510(k) clearance for the CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE). This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on August 4, 2023, 255 days after receiving the submission on November 22, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K223507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2022 |
| Decision Date | August 04, 2023 |
| Days to Decision | 255 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 |