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K Number
K980793
Device Name
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
Manufacturer
ROLENCE ENTERPRISE CO. LTD.
Date Cleared
1998-05-15

(74 days)

Product Code
EBF,EBE
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA letter about the Q-Luxpro V/Q-Luxpro II Light Cure Unit does not contain any information about acceptance criteria or a study proving that the device meets such criteria. The letter is a 510(k) premarket notification response, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The information provided is administrative and focuses on regulatory compliance for marketing the device. It does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes or data provenance for any test sets.
  3. Number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Information on standalone algorithm performance.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The letter simply states the device's indications for use: "TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT." This describes the functionality but not performance metrics or how they were proven.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.