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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K071981
Device Name BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
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 Number872.4850
Classification Product Code
ELC  
Date Received07/18/2007
Decision Date 10/26/2007
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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