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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K162856
Device Name Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
Applicant
Bonart Co., Ltd.
# 80, Wuxuan St.,
Keelung City,  TW 20446
Applicant Contact Bankson Tsai
Correspondent
Magpie Tech. Corp.
550 Yorbita Rd.
La Puente,  CA  91744
Correspondent Contact Eric L. Ong
Regulation Number872.4200
Classification Product Code
EGS  
Date Received10/12/2016
Decision Date 07/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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