The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart Art-l3 Led Curing Light.
| Device ID | K062289 |
| 510k Number | K062289 |
| Device Name: | BONART ART-L3 LED CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L Walnut, CA 91789 |
| Contact | Eric L Ong |
| Correspondent | Eric L Ong BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L Walnut, CA 91789 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-07 |
| Decision Date | 2007-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873120819 | K062289 | 000 |
| 04719873120802 | K062289 | 000 |
| 04719873120567 | K062289 | 000 |
| 04719873120543 | K062289 | 000 |