The following data is part of a premarket notification filed by Rolence Enterprise Co. Ltd. with the FDA for Cu-80 Light Cure Unit, Document No. A715676.
| Device ID | K942198 |
| 510k Number | K942198 |
| Device Name: | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 |
| Classification | Activator, Ultraviolet, For Polymerization |
| 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 | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-05 |
| Decision Date | 1994-05-27 |