OK Handpiece

Handpiece, Air-powered, Dental

Jaintek Co.,Ltd

The following data is part of a premarket notification filed by Jaintek Co.,ltd with the FDA for Ok Handpiece.

Pre-market Notification Details

Device IDK221814
510k NumberK221814
Device Name:OK Handpiece
ClassificationHandpiece, Air-powered, Dental
Applicant Jaintek Co.,Ltd #302, 419, Byeolmang-ro, Danwon-gu Ansan-si,  KR 15605
ContactJung Gun Lee
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2022-06-22
Decision Date2022-07-15

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