The following data is part of a premarket notification filed by Promident Llc with the FDA for Clear Blue Digi Led Curing Light.
| Device ID | K172426 |
| 510k Number | K172426 |
| Device Name: | Clear Blue Digi LED Curing Light |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Promident LLC 618 Corporate Way Unit 1 Valley Cottage, NY 10989 |
| Contact | Gary Kris |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2017-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862314000301 | K172426 | 000 |