JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU

Handpiece, Air-powered, Dental

JINDELL MEDICAL INSTRUMENTS CO., LTD.

The following data is part of a premarket notification filed by Jindell Medical Instruments Co., Ltd. with the FDA for Jindell High Spped Air Turbine Handpiece, Models Sw, Sp, Su, Etu, Mu.

Pre-market Notification Details

Device IDK062740
510k NumberK062740
Device Name:JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
ClassificationHandpiece, Air-powered, Dental
Applicant JINDELL MEDICAL INSTRUMENTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
ContactKe-min Jen
CorrespondentKe-min Jen
JINDELL MEDICAL INSTRUMENTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-13
Decision Date2006-11-02
Summary:summary

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