The following data is part of a premarket notification filed by Dentlight Inc. with the FDA for Fusion Plus Curing Light.
| Device ID | K180065 |
| 510k Number | K180065 |
| Device Name: | FUSION Plus Curing Light |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DentLight Inc. 1825 Summit Ave. Ste 210 Plano, TX 75074 |
| Contact | Richard Liu |
| Correspondent | Richard Liu DentLight Inc. 1825 Summit Ave. Ste 210 Plano, TX 75074 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-09 |
| Decision Date | 2019-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860179001068 | K180065 | 000 |
| 00860179001037 | K180065 | 000 |