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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 K160140
Device Name DENTRIa series
Applicant
Hdx Will Corp.
#105, 201, 202, 203, 204, 38
Osongsaengmyeong 4-Ro, Osong-Eup Heungdeok-Gu
Cheongju-Si,  KR 28161
Applicant Contact Hyung-suk Oh
Correspondent
Hdx Will Corp.
#105, 201, 202, 203, 204, 38
Osongsaengmyeong 4-Ro, Osong-Eup Heungdeok-Gu
Cheongju-Si,  KR 28161
Correspondent Contact Hyung-suk Oh
Regulation Number892.1750
Classification Product Code
OAS  
Date Received01/21/2016
Decision Date 09/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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