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Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.

Metamorphosis, a nanohybrid composite, is a light-cured, resin-based, dental restorative designed for direct placement.

The provided text is a 510(k) summary for a dental composite restorative material called "Metamorphosis." It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data or algorithm-based evaluations.

The 510(k) submission process for devices like composite restorative materials typically relies on demonstrating substantial equivalence to legally marketed predicate devices, often through bench testing for physical characteristics and biocompatibility, rather than clinical efficacy studies with predefined acceptance criteria for performance like accuracy or sensitivity found in diagnostic or AI-driven devices.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory classification, intended use, and substantial equivalence based on a comparison of characteristics and function to existing products.

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