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K Number
K023748
Device Name
FLASH-LITE II LED DENTAL CURING LIGHT
Manufacturer
DISCUS DENTAL, INC.
Date Cleared
2003-01-17

(70 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 photo-activated, visible light cured dental restorative materials.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental curing light, not a study report or a document detailing acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, and does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for a test set or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  6. Results of a standalone algorithm performance study.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This document is a formal communication from the FDA granting market clearance, not a technical report or clinical study summary.

§ 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.