Cleared Traditional

GlasIonomer FX ULTRA

K222253 · Shofu Dental Corporation · Dental
Sep 2022
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K222253 is an FDA 510(k) clearance for the GlasIonomer FX ULTRA, 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 September 22, 2022, 57 days after receiving the submission on July 27, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K222253 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2022
Decision Date September 22, 2022
Days to Decision 57 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