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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 K262074
Device Name Any-Zircos
Applicant
Mediclus Co., Ltd.
# 1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Applicant Contact Ku Da Hyeon
Correspondent
Mediclus Co., Ltd.
# 1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Correspondent Contact Ku Da Hyeon
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/22/2026
Decision Date 08/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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