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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 K253973
Device Name Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
Applicant
Liaoning Upcera Co., Ltd.
#122 Xianghuai Rd., Economic Development Zone
Benxi,  CN 117004
Applicant Contact Li Luo
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/11/2025
Decision Date 01/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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