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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 K221814
Device Name OK Handpiece
Applicant
Jaintek Co.,Ltd
#302, 419, Byeolmang-ro, Danwon-gu
Ansan-si,  KR 15605
Applicant Contact Jung Gun Lee
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/22/2022
Decision Date 07/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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