BONART ART-L5 LED CORDLESS CURING LIGHT

Activator, Ultraviolet, For Polymerization

BONART CO. LTD.

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.

Pre-market Notification Details

Device IDK082971
510k NumberK082971
Device Name:BONART ART-L5 LED CORDLESS CURING LIGHT
ClassificationActivator, Ultraviolet, For Polymerization
Applicant BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L Walnut,  CA  91789
ContactEric L Ong
CorrespondentEric L Ong
BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L Walnut,  CA  91789
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-06
Decision Date2008-11-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719873120550 K082971 000
04719873120536 K082971 000
04719873120055 K082971 000

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