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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K262523
Device Name Amber Arte
Applicant
Hass Corp.
77-14, Gwahakdanji-Ro
Gangneung,  KR 25452
Applicant Contact Yongsu Kim
Correspondent
LK Consulting Group USA, Inc.
2552 Walnut Ave. Suite 230
Tustin,  CA  92780
Correspondent Contact Priscilla Chung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/22/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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