The following data is part of a premarket notification filed by Dentlight Inc. with the FDA for Fusion Curing Light.
| Device ID | K052593 |
| 510k Number | K052593 |
| Device Name: | FUSION CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTLIGHT INC. 4404 BRECKINRIDGE BLVD. DUITE 400 Richardson, TX 75082 |
| Contact | Richard Liu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-21 |
| Decision Date | 2005-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860179001006 | K052593 | 000 |