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K Number
K992357
Device Name
EASY-CURE (CURING AND WHITENING LIGHT)
Manufacturer
ICS OF NORTH AMERICA, INC.
Date Cleared
1999-08-30

(47 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

This device is intended for use in:

  1. Source of illumination for curing dental restorative materials,
  2. Assisting in the whitening process in dental office.
Device Description

The Easy-Cure™ Curing and Whitening Light is comprised of a high-intensity light source filtered and transmitted through an optical fiber for the curing of composite resins and as an aid in the whitening of teeth. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.

AI/ML Overview

This looks like a 510(k) submission for a dental curing and whitening light, which is a physical device, not an AI/ML powered software. Therefore, the requested information about acceptance criteria and clinical study results, including details like sample size, ground truth, expert qualifications, and MRMC studies, are not applicable in the context of this specific document.

The document primarily focuses on establishing "substantial equivalence" to existing predicate devices based on its intended use, design, and performance characteristics (like light spectrum and voltage). It does not present a study with performance metrics in the way one would for an AI/ML device.

Here's why the requested information isn't present in this document:

  • Acceptance Criteria & Device Performance: The document states "Performance standards: None established under section 514." This means there aren't specific universally mandated performance metrics that the device must meet in the same way an AI algorithm might have. Substantial equivalence is determined by comparing its specifications and intended use to existing, legally marketed devices.
  • Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all concepts related to the validation of software algorithms, particularly AI/ML models, where performance is measured against a "ground truth" established by experts on a dataset. A dental light curing device doesn't operate in this manner. Its "performance" is typically assessed through engineering specifications (light intensity, wavelength, safety features) and comparison to predicate devices, rather than statistical analysis on a clinical dataset in the AI/ML sense.

Instead of the requested table, the document achieves its goal by demonstrating:

  • Description: The device emits filtered light in the range of 400 to 500 nm and accepts 100-230 VAC.
  • Indications for Use: Curing dental restorative materials and assisting in tooth whitening.
  • Substantial Equivalence: It lists several predicate devices (e.g., Plasma Arc Curing system, Ardent Radiance Curing Light, Spectrum 800 Curing Unit) that it claims to be substantially equivalent to, based on similar technology, indications, and safety.

In summary, this document is for a traditional medical device (a light source), not an AI/ML software. Therefore, the questions posed about AI/ML device validation are not applicable.

§ 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.