Cleared Traditional

?FLNT Base? and ?FLNT Temp?

K253380 · Liaoning Upcera Co., Ltd. · Dental
Mar 2026
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K253380 is an FDA 510(k) clearance for the ?FLNT Base? and ?FLNT Temp?, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on March 2, 2026, 153 days after receiving the submission on September 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K253380 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2025
Decision Date March 02, 2026
Days to Decision 153 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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