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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K082971
Device Name BONART ART-L5 LED CORDLESS CURING LIGHT
Applicant
Bonart Co., Ltd.
398 S. Lemon Creek Dr.
Suite L
Walnut,  CA  91789
Applicant Contact ERIC L ONG
Correspondent
Bonart Co., Ltd.
398 S. Lemon Creek Dr.
Suite L
Walnut,  CA  91789
Correspondent Contact ERIC L ONG
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/06/2008
Decision Date 11/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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