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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K210789
Device Name EQ-PEX
Applicant
Meta Systems Co., Ltd.
#1214-18, Sicox Tower 12f, 484, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13229
Applicant Contact Hyejin Park
Correspondent
Meta Systems Co., Ltd.
#1214-18, Sicox Tower 12f, 484, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13229
Correspondent Contact Hyejin Park
Classification Product Code
LQY  
Date Received03/16/2021
Decision Date 10/20/2021
Decision Substantially Equivalent (SESE)
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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