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K Number
K152192
Device Name
LED Curing Light
Manufacturer
MONITEX INDUSTRIAL CO., LTD.
Date Cleared
2017-04-07

(611 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

LED Curing Light LD-M4 . LD-M4P is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 420-490 nm by dental professionals.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter for the LED Curing Light LD-M4, LD-M4P (K152192) does not contain the specific information required to answer your request.

This document is a notification of substantial equivalence for a medical device and primarily focuses on regulatory approval. It does not include:

  • Acceptance criteria and reported device performance (Table 1): While it states the device cures materials in the 420-490 nm wavelength, it doesn't provide specific performance metrics, quality standards, or the criteria for what would be considered "acceptable."
  • Study details: There is no mention of a specific study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets or how ground truth was established.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and is intended for the same use as a device already on the market. The FDA's substantial equivalence determination does not usually involve a detailed breakdown of a new study's results in the public summary letter, but rather a comparison to an existing device.

To obtain the information you're looking for, you would typically need to consult the full 510(k) submission, which contains the detailed technical and performance data submitted by the manufacturer to the FDA. This information is not typically made public in its entirety, though summaries may be available.

§ 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.