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K Number
K012740
Device Name
CLEARFIL AP-X
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-14

(31 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
K943168
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CLEARFIL AP-X is indicated for the following applications:

  1. Class I, II, V restorations of posterior teeth
  2. Class III, IV, V restorations of anterior teeth
  3. Cervical cavities or defects involving root surfaces
Device Description

This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.

AI/ML Overview

This is a 510(k) premarket notification for a dental material (CLEARFIL AP-X), not a medical device that would involve a study with acceptance criteria in the typical sense (performance metrics, ground truth, expert review, etc.).

The submission focuses on a change of manufacturer name and address for an already cleared device (predicate device K943168). Therefore, the provided documentation explicitly states that:

  • "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes."
  • "This device is essentially the same as CLEARFIL AP-X manufactured by Kuraray Co., Ltd. (K943168). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL AP-X."

This means there's no new study conducted to establish acceptance criteria or demonstrate device performance for this specific 510(k) submission (K012740). The acceptance of this submission is based on the substantial equivalence to the predicate device, which has already met its regulatory requirements.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not applicable to this specific 510(k) submission as it is merely an administrative change.

§ 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.