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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dental abutment design software for dental laboratory
510(k) Number K221107
Device Name TRUST
Rgorithm Korea
A-1502, 606 Seobusaet-gil, Guemcheon-gu, Seoul, 08504,
Republic of Korea
Geumcheon-gu,  KR 08504
Applicant Contact Jun Ho Song
Wise Company Inc.
#507, #508, 166 Gasan digital 2-ro
Geumcheon-gu,  KR 08503
Correspondent Contact Sanglok Lee
Regulation Number872.3630
Classification Product Code
Date Received04/15/2022
Decision Date 07/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No