Cleared Traditional

Demi Pro

K253461 · Meta Systems Co., Ltd. · Dental
Oct 2025
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K253461 is an FDA 510(k) clearance for the Demi Pro, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Meta Systems Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 14, 2025, 7 days after receiving the submission on October 7, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K253461 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2025
Decision Date October 14, 2025
Days to Decision 7 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBZ — Activator, Ultraviolet, For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070

Similar Devices — EBZ Activator, Ultraviolet, For Polymerization

All 212
Bluemoon
K242386 · Genoss Co., Ltd. · May 2025
LED Curing Lights (DB686 HALO)
K243921 · Foshan Coxo Medical Instrument Co., Ltd. · Apr 2025
LED Curing Light (C01-X, C02-X)
K250009 · Premium Plus (Dongguan) Limited · Apr 2025
LOOP? LED Curing Light System (CLK01)
K241238 · Garrison Dental Solutions, LLC · Aug 2024
Curing Light, Model: MaxCure 9
K223414 · Guilin Refine Medical Instrument Co., Ltd. · Nov 2023
BASE290 LED Curing Light
K233518 · Handpiece Headquarters · Nov 2023