The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart Art-l5 Led Cordless Curing Light.
Device ID | K082971 |
510k Number | K082971 |
Device Name: | BONART ART-L5 LED CORDLESS 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 | 2008-10-06 |
Decision Date | 2008-11-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04719873120550 | K082971 | 000 |
04719873120536 | K082971 | 000 |
04719873120055 | K082971 | 000 |