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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K253380
Device Name “FLNT Base” and “FLNT Temp”
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 Jinfeng Ning
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
EBI  
Date Received09/30/2025
Decision Date 03/02/2026
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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