Cleared Traditional

GlasIonomer FX-LC

K252808 · Shofu Dental Corporation · Dental
Dec 2025
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K252808 is an FDA 510(k) clearance for the GlasIonomer FX-LC, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on December 9, 2025, 97 days after receiving the submission on September 3, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K252808 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2025
Decision Date December 09, 2025
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275