(28 days)
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.
§ 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.