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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 K000510
Device Name ART-M1, MODEL M1-1-ART-A1
Applicant
Bonart Co., Ltd.
Rm. 405, #3 Wuchuan 1st Rd.
Hsingchang, Taipei Hsien,  TW
Applicant Contact BANKSON TSAI
Correspondent
Bonart Co., Ltd.
Rm. 405, #3 Wuchuan 1st Rd.
Hsingchang, Taipei Hsien,  TW
Correspondent Contact BANKSON TSAI
Regulation Number872.4850
Classification Product Code
ELC  
Date Received02/15/2000
Decision Date 05/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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