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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K100785
Device Name BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
Applicant
Bonart Co., Ltd.
398 S. Lemon Creek Dr.
Suite G
Walnut,  CA  91789
Applicant Contact ERIC L ONG
Correspondent
Bonart Co., Ltd.
398 S. Lemon Creek Dr.
Suite G
Walnut,  CA  91789
Correspondent Contact ERIC L ONG
Regulation Number872.4200
Classification Product Code
EBW  
Date Received03/19/2010
Decision Date 12/03/2010
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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