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K Number
K033201
Device Name
LA500 BLUE LIGHT
Manufacturer
APOZA ENTERPRISE CO. LTD.
Date Cleared
2003-12-02

(61 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
K020091
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

LA500 Blue Light is a visible curing unit programmed for This polymerization of light cured materials by dental professionals..

Device Description

APOZA CURING LIGHT, Models: LA500 Blue Light. The intended use of the LA500 Blue Light is for the polymerization of light cure material and activation of dental bleaching materials.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a dental curing light, primarily focusing on its equivalence to a predicate device and its intended use. There is no mention of specific performance metrics, test sets, ground truth establishment, or expert involvement in a study.

§ 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.