K242386 is an FDA 510(k) clearance for the Bluemoon. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Genoss Co., Ltd. (Suwon-Si, CN). The FDA issued a Cleared decision on May 5, 2025, 266 days after receiving the submission on August 12, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K242386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2024 |
| Decision Date | May 05, 2025 |
| Days to Decision | 266 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 |