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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K212254
Device Name DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
Applicant
HDX Will Corp.
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro
Osong-eup, Heungdeok-gu
Cheongju-si,  KR 28161
Applicant Contact Kaon Kim
Correspondent
HDX Will Corp.
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro
Osong-eup, Heungdeok-gu
Cheongju-si,  KR 28161
Correspondent Contact Kaon Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/19/2021
Decision Date 10/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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