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 |