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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)

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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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Excite® Self Etch is a light cured adhesive designed to bond composite and compomer to enamel and dentin. It is also an adhesive for light initiated resin cements used in conjunction with "transparent" indirect restorations, i.e. all ceramic (except zirconiumoxide) and composite restorations.

Excite Self Etch is contraindicated for use as an adhesive with self-curing resin cements. Dual curing materials must be light initiated. This product is also contraindicated for zirconiumoxide ceramic restorations and for pulp capping.

Not Found

This document is a FDA 510(k) clearance letter for a dental adhesive device named "Excite Self Etch". It does not contain information about acceptance criteria or a study that proves the device meets such criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information.

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Excite adhesive is for use in clinical situations in which adhesion between light initiated resin based restorative or cementation materials and dentin and enamel is desired.

• Adhesion of direct light initiated resin based restorations or repairs including: composite, ceromer and . compomer to enamel and dentin.
• Adhesion of light initiated resin based cementation materials to enamel and dentin during final . placement of indirect restorations including: veneers, inlays, onlays, and single and multiple unit restorations.
• As a resin based wetting agent to improve adhesion between silanated ceramic or ceromer surfaces . (indirect restorations, repairs) and light initiated resin cements and restoratives.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for the "Excite" adhesive, establishing its substantial equivalence to a predicate device. It details the indications for use but does not include any performance data, study design, or acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.

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