K935718 is an FDA 510(k) clearance for the JEDENTAL VLC DENTAL CURING LIGHT. This device is classified as a Light, Fiber Optic, Dental (Class I - General Controls, product code EAY).
Submitted by Jedental Co., Inc. (Southampton, US). The FDA issued a Cleared decision on January 26, 1994, 57 days after receiving the submission on November 30, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4620.
| 510(k) Number | K935718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1993 |
| Decision Date | January 26, 1994 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EAY — Light, Fiber Optic, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4620 |