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K Number
K080035
Device Name
LED CURING LIGHT
Manufacturer
MONITEX INDUSTRIAL CO., LTD.
Date Cleared
2008-03-03

(56 days)

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

This" LED Curing Light GT-1200" is for the polymerization of light cure materials.

Device Description

Not Found

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a dental device (LED Curing Light GT-1200) and contains communications from the FDA regarding its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, a specific study proving device performance, sample sizes for test or training sets, expert qualifications, or ground truth establishment.

This document is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

§ 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.