Cleared Traditional

ID LIGHT CURE SYSTEM

K250804 · Id Korea Co., Ltd. · Dental
Jun 2025
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K250804 is an FDA 510(k) clearance for the ID LIGHT CURE SYSTEM, a Coating, Filling Material, Resin (Class II — Special Controls, product code EBD), submitted by Id Korea Co., Ltd. (Dong-Gu, KR). The FDA issued a Cleared decision on June 4, 2025, 79 days after receiving the submission on March 17, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3310.

Submission Details

510(k) Number K250804 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2025
Decision Date June 04, 2025
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBD — Coating, Filling Material, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3310

Similar Devices — EBD Coating, Filling Material, Resin

All 50
visio.lign color, visio.lign shield
K240735 · Bredent GmbH & Co. KG · Dec 2024
RODIN Palette Naturalizing Kit
K223365 · Belport Company, Inc., Gingi-Pak · Mar 2023
VITA Akzent LC
K211854 · Vita Zahnfabrik GmbH H Rauter & CO · Nov 2021
Nano Varnish, Plaquit, Lightpaint on Surface
K162408 · Dreve Dentamid GmbH · Apr 2018
SHOFU RESIN GLAZE
K163568 · Shofu Dental Corporation · Aug 2017
OPTIGLAZE COLOR
K133836 · GC America, Inc. · Mar 2014