The following data is part of a premarket notification filed by Rolence Enterprise Co. Ltd. with the FDA for Cute-lite I Light Cure Unit.
| Device ID | K991863 |
| 510k Number | K991863 |
| Device Name: | CUTE-LITE I LIGHT CURE UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ROLENCE ENTERPRISE CO. LTD. 18-3 LANE 231 PU CHUNG RD. Chungli, TW |
| Contact | Sterling Cheng |
| Correspondent | Sterling Cheng ROLENCE ENTERPRISE CO. LTD. 18-3 LANE 231 PU CHUNG RD. Chungli, TW |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-07-19 |