Cleared Traditional

EQUIA LC ONE

K250953 · GC America, Inc. · Dental
Sep 2025
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K250953 is an FDA 510(k) clearance for the EQUIA LC ONE, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on September 19, 2025, 175 days after receiving the submission on March 28, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K250953 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2025
Decision Date September 19, 2025
Days to Decision 175 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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