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K Number
K021427
Device Name
CLEARFIL SA PRIMER
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2002-06-07

(35 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K943166,K012432
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CLEAFIL SA PRIMER is indicated for the following applications:

  1. A dentin and enamel bonding system for composite resin restoration
Device Description

CLEARFIL SA PRIMER is the adhesion primer to enhance the bond strength to dentine of CLEARFIL PHOT BOND when used in conjunction with it. Therefore this device is classified into Adhesion primer, CFR 21 Section 872.3200, because it is a device containing dimethacrylate monomer intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a composite filling.

AI/ML Overview

This document is a 510(k) summary for a dental adhesive primer (CLEARFIL SA PRIMER) and does not describe a study involving device performance metrics relevant to AI or diagnostic accuracy. Therefore, I cannot provide information on acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth as these are not applicable to the content provided.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety.

Here's why the requested information cannot be extracted from the provided text:

  • Type of Device: The device is a "Resin tooth bonding agent" used in conjunction with other dental materials for composite resin restorations. It's a chemical formulation, not a diagnostic imaging device or an AI-powered system that would generate performance metrics like sensitivity, specificity, or accuracy.
  • Nature of the Submission: A 510(k) submission primarily aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing formulations, materials, manufacturing processes, and intended use, rather than conducting new clinical trials with statistical endpoints of diagnostic accuracy.
  • Content: The summary explicitly states:
    • "This device is a same solution of N-Methacryloy1-5-Aminosalicilic acid and is essentially the same as the adhesion primer, SA PRIMER, of CLEARFIL LINER BOND SYSTEM (K943166)."
    • "Therefore the technological characteristics of this device is substantially same to CLEARFIL LINER BOND SYSTEM (K943166)."
    • "Therefore the safety of this device are completely the same as SA PRIMER of CLEARFIL LINER BOND SYSTEM."

This indicates that the "study" demonstrating performance and safety is implicitly the performance and safety data of the predicate device, or simply a chemical/material comparison, not a clinical study designed to measure diagnostic performance or compare human readers with and without AI.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.