K173876 is an FDA 510(k) clearance for the Cybird LED Curing Light. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Dxm Co., Ltd. (Goyang-Si, KR). The FDA issued a Cleared decision on January 24, 2018, 34 days after receiving the submission on December 21, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K173876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2017 |
| Decision Date | January 24, 2018 |
| Days to Decision | 34 days |
| Submission Type | Special |
| 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 |