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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 K081550
Device Name BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
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 Received06/03/2008
Decision Date 08/28/2008
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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