(27 days)
CLEARFIL CORE NEW BOND is indicated for the following application: CLEARFIL CORE NEW BOND is indicated for the formers build was EARFIL CORE NWW DOND is material we care build-up is required. 1)
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 document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for the CLEARFIL CORE NEW BOND device.
The document is a 510(k) submission for a name and address change for an existing device. It explicitly states:
- "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes." (Section 3)
- "This device is essentially the same as CLEARFIL CORE NEW BOND manufactured by Kuraray Co., Ltd. (K871637). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL CORE NEW BOND." (Section 6)
Therefore, all the requested information about performance, studies, and validation would have been part of the original K871637 submission, not this K012703 submission. The current document focuses solely on establishing substantial equivalence due to a manufacturing entity change, not re-evaluating the device's performance.
§ 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.