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K Number
K163605
Device Name
LEDEX WL070+
Manufacturer
DENTMATE TECHNOLOGY CO., LTD.
Date Cleared
2017-01-19

(29 days)

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

LEDEX WL-070+ is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

Device Description

Not Found

AI/ML Overview

This is a 510(k) summary document for K163605, a dental curing light, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and training/test sets for an AI/ML device cannot be extracted from this document. The document describes the FDA's clearance of a physical medical device (LEDEX WL070+) and confirms its substantial equivalence to a predicate device, based on its intended use as a visible curing unit for polymerization of dental light-cured materials.

The provided text does not contain any details about the acceptance criteria or a study proving that an AI/ML device meets such 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.