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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 K240912
Device Name Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
Applicant
Anhui Miisen Intelligence Technology Co., Ltd.
# 6 Bldg., S. Huoyanshan Rd.,
Economic Development Zone, Fanchang District
Wuhu,  CN 241200
Applicant Contact Charles Shen
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Jinfeng Ning
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/03/2024
Decision Date 05/31/2024
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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