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K Number
K033970
Device Name
CLEARFIL PHOTO CORE PLT
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2004-03-26

(95 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K012705,K023002
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Core build up of vital or non vital tooth
Device Description

This device is a dental composite resin restorative material. The composite resin is substantially equivalent to CLEARFIL PHOTO CORE (K012705) as the chemical composition, ingredients and intended use are the same as those of the predicate device. Also, this device is different from CLEARFIL PHOTO CORE (K012705) in that it is filled in disposable tips, but the disposable tips are substantially equivalent to those that are used in CLEARFIL AP-X PLT (K012705).

AI/ML Overview

The provided text appears to be a 510(k) summary for a medical device called "CLEARFIL PHOTO CORE PLT," a light-cured composite resin for core build-up in dentistry. This document is a regulatory submission to the FDA for market clearance, not a study report detailing acceptance criteria and performance data in the context of clinical or performance studies.

Therefore, the document does not contain the information requested in your prompt regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth.
  • Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used.
  • Sample size for the training set or how ground truth for the training set was established.

The document primarily focuses on establishing "substantial equivalence" of the new device to existing predicate devices based on chemical composition, ingredients, and intended use, rather than rigorous performance testing against pre-defined acceptance criteria for a novel device or AI algorithm. It states: "This device is a dental composite resin restorative material. The composite resin is substantially equivalent to CLEARFIL PHOTO CORE (K012705) as the chemical composition, ingredients and intended use are the same as those of the predicate device."

§ 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.