The following data is part of a premarket notification filed by Rolence Enterprise Co. Ltd. with the FDA for Cu-100a Light Cure Unit.
| Device ID | K980792 |
| 510k Number | K980792 |
| Device Name: | CU-100A LIGHT CURE UNIT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | ROLENCE ENTERPRISE CO. LTD. 226 KONG-SHIEH-SIR VILLAGE Chungli,taiwan, TW |
| Contact | Sterling Cheng |
| Correspondent | Sterling Cheng ROLENCE ENTERPRISE CO. LTD. 226 KONG-SHIEH-SIR VILLAGE Chungli,taiwan, TW |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-05-15 |