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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 K161713
Device Name Dentium CAD/CAM Abutments
Dentium Co., Ltd
150, Eondong-ro, Giheung-gu
yongin-si,  KR 443-270
Applicant Contact sangpil yoon
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact linda k. schulz
Regulation Number872.3630
Classification Product Code
Date Received06/21/2016
Decision Date 12/16/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No