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1. Core build up of vital or non vital tooth

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).

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."

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CLEARFIL PHOTO CORE is indicated for the following applications: Restoration where a light-curing composite for core build-up is required.

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 be used for core build-up.

The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance for a medical device.

The document is a 510(k) summary for a dental material named "CLEARFIL PHOTO CORE" by KURARAY MEDICAL INC. It states that the submission aims to alter the name and address of the manufacturer and not to introduce other changes. It also explicitly states that the device is essentially the same as a previously cleared predicate device (CLEARFIL PHOTO CORE by Kuraray Co., Ltd., K882006) and that its technological characteristics, chemical ingredients, and safety are completely the same.

Therefore, the document relies on the substantial equivalence to the predicate device to establish safety and effectiveness, rather than presenting new studies with acceptance criteria, performance data, or ground truth establishment details.

In summary, none of the requested information regarding acceptance criteria and study details is present in the provided text.

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