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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K143411
Device Name TRAUS ENDO
Applicant
Saeshin Precision Co., Ltd.
52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Daegu,  KR 711814
Applicant Contact Sae Kwan Choi
Correspondent
Saeshin Precision Co., Ltd.
52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Daegu,  KR 711814
Correspondent Contact Sae Kwan Choi
Regulation Number872.4200
Classification Product Code
EKX  
Date Received11/28/2014
Decision Date 06/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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