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• Class III and V restorations; particularly areas of cervical erosion, a. abfraction lesions and root surface caries.
• Restoration of primary teeth b.
• As a base or liner C .
• Core build-ups/block-outs (particularly of vital teeth) ర .
• Cases in which a radiopaque restoration is required e .

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for the Fuji II LC Capsule, which is a dental material. It confirms that the device is substantially equivalent to a legally marketed predicate device and lists its indications for use.

Therefore, I cannot extract any of the requested information regarding acceptance criteria or a study proving device performance from this document.

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Fuji II is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications:

• Restoration of primary teeth.
• Core build-ups.
• Class III, V and limited Class I cavities.

Fuji II is a self-cure glass ionomer material.

The provided text is an FDA 510(k) clearance letter for a dental restorative material called "Fuji II". This document confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

The letter only states:

• Trade Name: Fuji II
• Regulatory Class: II
• Product Code: EMA
• Indications For Use: Restoration of primary teeth, Core build-ups, Class III, V and limited Class I cavities.
• Substantial Equivalence: The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

To answer your request, information regarding performance data, testing methods, sample sizes, ground truth establishment, or expert involvement would need to be found in the actual 510(k) submission document itself, which is not provided here. The clearance letter only references the submission and its outcome.

Ask a specific question about this device

Ask a specific question about this device