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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K152125
Device Name Oral Surgery System and Accessories
Applicant
Bonart Co., Ltd.
4f-1, # 3 Wuquan 1st Rd.
Xinzhuang Dist.,  TW 24892
Applicant Contact BANKSON TSAI
Correspondent
Magpie Tech. Corp.
550 Yorbita Rd.
La Puente,  CA  91744
Correspondent Contact ERIC L. ONG
Regulation Number872.4120
Classification Product Code
DZI  
Date Received07/31/2015
Decision Date 08/15/2016
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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