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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name handpiece, air-powered, dental
510(k) Number K152146
Device Name High Speed Handpieces and Accessories
Applicant
CODENT TECHNICAL INDUSTRY CO., LTD.
5F., No.90, Luke 5th Rd., Luzhu District
Kaohsiung City,  TW 82151
Applicant Contact Chin-Ting Wen
Correspondent
CODENT TECHNICAL INDUSTRY CO., LTD.
5F., No.90, Luke 5th Rd., Luzhu District
Kaohsiung City,  TW 82151
Correspondent Contact Chin-Ting Wen
Regulation Number872.4200
Classification Product Code
EFB  
Date Received08/03/2015
Decision Date 12/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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