The following data is part of a premarket notification filed by Rolence Ent. Inc. with the FDA for Ultra-lite 200e Light Cure Unit.
| Device ID | K023545 |
| 510k Number | K023545 |
| Device Name: | ULTRA-LITE 200E LIGHT CURE UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ROLENCE ENT. INC. 18-3 LANE 231 PU CHUNG RD. Chungli, TW 320 |
| Contact | Sterling Cheng |
| Correspondent | Sterling Cheng ROLENCE ENT. INC. 18-3 LANE 231 PU CHUNG RD. Chungli, TW 320 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-22 |
| Decision Date | 2002-12-30 |