Cleared Traditional

BASE290 LED Curing Light

K233518 · Handpiece Headquarters · Dental
Nov 2023
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K233518 is an FDA 510(k) clearance for the BASE290 LED Curing Light, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on November 2, 2023, 1 days after receiving the submission on November 1, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K233518 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2023
Decision Date November 02, 2023
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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
Demi Pro
K253461 · Meta Systems Co., Ltd. · Oct 2025
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