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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 K062740
Device Name JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
Applicant
Jindell Medical Instruments Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
Jindell Medical Instruments Co., Ltd.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/13/2006
Decision Date 11/02/2006
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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