The following data is part of a premarket notification filed by Rolence Enterprise Co. Ltd. with the FDA for Cu-200 Light Cure Unit.
| Device ID | K960364 |
| 510k Number | K960364 |
| Device Name: | CU-200 LIGHT CURE UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ROLENCE ENTERPRISE CO. LTD. 226 KONG-SHIEH-SIR VILLAGE Chungli, Taiwan R.o.c., TW |
| Contact | Sterling Cheng |
| Correspondent | Sterling Cheng ROLENCE ENTERPRISE CO. LTD. 226 KONG-SHIEH-SIR VILLAGE Chungli, Taiwan R.o.c., TW |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-25 |
| Decision Date | 1996-04-15 |