The following data is part of a premarket notification filed by Discus Dental, Inc. with the FDA for Flashlite Rebel*.
| Device ID | K073518 |
| 510k Number | K073518 |
| Device Name: | FLASHLITE REBEL* |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DISCUS DENTAL, INC. 8550 HIGUERA ST. Culver City, CA 90232 -2522 |
| Contact | Vivian Lai |
| Correspondent | Morten Simon Christenson UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-12-14 |
| Decision Date | 2007-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813CR10830 | K073518 | 000 |
| D813CR1079R0 | K073518 | 000 |
| D813CR1079P0 | K073518 | 000 |
| D813CR1079ABC0 | K073518 | 000 |
| D813CR10790 | K073518 | 000 |