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Excite® F is a light-curing, total etch, single component adhesive with fluoride release intended for use in clinical situations for:

• Adhesive for direct light-curing and dual curing composite and compomer restorations

• Adhesive for indirect all-ceramic and composite restorations (inlays, onlays, veneers; only light-curing)

Excite® F DSC is a total etch, dual-curing and light curing adhesive with fluoride release intended for use in clinical situations for:

• Adhesive cementation of indirect, metal-free, translucent restorations (e.g. IPS Empress CAD, IPS Empress Esthetic) with dual or self curing luting composites (e.g. Variolink II)

• direct restorations and core build ups with dual and self curing compositions (e.g. Multicore)

• Direct restorations/cementation with light-curing composites (e.g. Tetric EvoCeram, Variolink II Base, Heliomolar)

Not Found

This is a 510(k) premarket notification for a dental resin tooth bonding agent (Excite F & Excite F DSC). The document is a clearance letter from the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The information you're looking for (table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is typically found in the scientific and clinical studies submitted as part of the 510(k) application, not in the FDA's final clearance letter.

Therefore, I cannot provide the requested information from the provided text.

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