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K Number
K062289
Device Name
BONART ART-L3 LED CURING LIGHT
Manufacturer
BONART CO. LTD.
Date Cleared
2007-01-03

(149 days)

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

Source of illumination for curing dental is restorative materials.

Device Description

BONART ART-L3 LED CURING LIGHT

AI/ML Overview

This letter is a 510(k) clearance for a dental curing light, a device whose performance is assessed through physical characteristics rather than diagnostic accuracy. Therefore, the questions related to AI/algorithm performance (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable in this context.

Summary of the Device:

  • Trade/Device Name: BONART ART-L3 LED CURING LIGHT
  • Regulation Number: 872.6070
  • Regulation Name: Ultraviolet Activator for Polymerization
  • Regulatory Class: II
  • Product Code: EBZ
  • Indication for Use: Source of illumination for curing dental restorative materials.

The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls provisions of the Act.

§ 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.