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This device is used for the following indications. All of these intended use are same to those of predicate devices.

1. Adhesion of metal posts, metal inlays, onlays, crown and bridges.
2. Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
3. Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures

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This document is a 510(k) premarket notification decision letter from the FDA regarding a dental product called "Alloy Primer" by Kuraray America, Incorporated. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter primarily:

• Confirms a review of the 510(k) notification.
• States that the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device, subject to general controls.
• Provides information on FDA regulations and resources.

The "Indications For Use" section (Page 2) lists the intended uses of the Alloy Primer and references similar predicate products, but this is not a study report or a performance validation.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, ground truth, or study methodologies from this document.

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