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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K193425
Device Name Pre-Milled Blank
Arum Dentistry Co. Ltd
1 Building, 44, Techno 8-ro
Yuseong-gu, Daejeon,  KR 34028
Applicant Contact Hwang-Heung Yeon
Aclivi, Llc
6455 Farley Road
Pinckney,  MI  48169
Correspondent Contact Chris Brown
Regulation Number872.3630
Classification Product Code
Date Received12/10/2019
Decision Date 03/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No