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K Number
K982615
Device Name
AIRDENT RADIANCE CURING LIGHT
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
1998-08-24

(28 days)

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

The AirDent "Radiance" Curing Light is indicated for use in curing dental composite resin materials for restoration of cavity preparation, curing of bonding and other photo-curing restorative materials as well as any application where a conventional dental curing light would be used.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the "AirDent "Radiance" Curing Light." This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of AI/machine learning or diagnostic performance.

Therefore, I cannot fulfill your request using the provided text. The requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for the training set) is specific to the evaluation of AI/ML or diagnostic devices, which is not what this FDA letter describes.

The document confirms that:

  • The device is a "AirDent "Radiance" Curing Light."
  • It is classified as Class II.
  • Its intended use is "curing dental composite resin materials for restoration of cavity preparation, curing of bonding and other photo-curing restorative materials as well as any application where a conventional dental curing light would be used."
  • The FDA determined the device is substantially equivalent to legally marketed predicate devices.

To answer your request, I would need a document detailing a clinical or performance study for a diagnostic or AI-powered medical device, including the specific criteria and methods used for its evaluation.

§ 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.