The following data is part of a premarket notification filed by Dentall Corporation with the FDA for Hi-light, Hi-light Plus.
| Device ID | K140432 |
| 510k Number | K140432 |
| Device Name: | HI-LIGHT, HI-LIGHT PLUS |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTALL CORPORATION 2651 E CHAPMAN AVE. SUITE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung DENTALL CORPORATION 2651 E CHAPMAN AVE. SUITE 110 Fullerton, CA 92831 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-20 |
| Decision Date | 2015-08-03 |
| Summary: | summary |