K250804 is an FDA 510(k) clearance for the ID LIGHT CURE SYSTEM. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Id Korea Co., Ltd. (Dong-Gu, KR). The FDA issued a Cleared decision on June 4, 2025, 79 days after receiving the submission on March 17, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K250804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2025 |
| Decision Date | June 04, 2025 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBD - Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |