The following data is part of a premarket notification filed by Dentlight Inc. with the FDA for Ultrafast, Ultrafast Plus, Ultrafast Lite.
| Device ID | K201387 |
| 510k Number | K201387 |
| Device Name: | Ultrafast, Ultrafast Plus, Ultrafast Lite |
| Classification | Laser, Dental, Soft Tissue |
| 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 | NVK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-27 |
| Decision Date | 2021-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860179001044 | K201387 | 000 |
| E2352171B1 | K201387 | 000 |