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K Number
K061695
Device Name
LED PROLUX 770
Manufacturer
PENG LIM ENTERPRISE CO., LTD.
Date Cleared
2006-09-14

(91 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
K040618
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.

Device Description

This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.

AI/ML Overview

This query cannot be answered from the provided text. The document is a 510(k) summary for a dental curing light. It discusses the device's intended use and compares it to a predicate device, concluding that it is substantially equivalent. However, it does not provide details about specific acceptance criteria, performance studies with reported metrics, sample sizes, expert qualifications, or detailed ground truth methodologies that would typically be found in a clinical study report. The document primarily focuses on regulatory approval based on equivalence rather than detailed performance study results against specific criteria.

§ 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.