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K Number
K250009
Device Name
LED Curing Light (C01-X, C02-X)
Manufacturer
Premium Plus (Dongguan) Limited
Date Cleared
2025-04-10

(98 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
K153514,K221194
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LED Curing Light is intended for use by trained dental professionals only for the purpose of light curing dental resins and composites.

Device Description

LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070). It is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has four curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually dental resins and composites.

AI/ML Overview

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.