K991863 is an FDA 510(k) clearance for the CUTE-LITE I LIGHT CURE UNIT. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Rolence Enterprise Co. , Ltd. (Chungli 320, TW). The FDA issued a Cleared decision on July 19, 1999, 48 days after receiving the submission on June 1, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K991863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1999 |
| Decision Date | July 19, 1999 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBZ — Activator, Ultraviolet, For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |