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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K223029
Device Name Perfit CL
Applicant
Vatech Mcis Co., Ltd.
2544, Nambuk-Daero, Idong-Eup, Cheoin-Gu
Yongin-Si,  KR 17137
Applicant Contact Kim Gyeong Rok
Correspondent
Mtechgroup
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/29/2022
Decision Date 06/20/2023
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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