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Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.

Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate based dental materials.

Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.

The provided document is a 510(k) premarket notification letter from the FDA to Apex Dental Materials, Inc. for their device, Injectafil™. This letter determines substantial equivalence and outlines regulatory requirements. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on the device's substantial equivalence to predicate devices, rather than a detailed report of clinical or performance study results.

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