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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 K133069
Device Name CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES
Applicant
CODENT TECHNICAL INDUSTRY CO., LTD.
5F., No.90, Luke 5th Rd., Luzhu District
SOUTHERN TAIWAN SCIENCE PARK
Kaohsiung City,  TW 82151
Applicant Contact CHIN-TING WEN
Correspondent
CODENT TECHNICAL INDUSTRY CO., LTD.
5F., No.90, Luke 5th Rd., Luzhu District
SOUTHERN TAIWAN SCIENCE PARK
Kaohsiung City,  TW 82151
Correspondent Contact CHIN-TING WEN
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received09/30/2013
Decision Date 10/24/2014
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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