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SE Epiphany Root Canal Sealant is intended for permanent obturation of root canals of teeth in combination with root canal points.

The subject device is a self-etch methacrylate resin root canal sealant in a catalyst/base paste formulation. Due to its self-etching and adhering properties, SE Epiphany Root Canal Sealant does not require the use of an etchant, primer or adhesive to achieve its intended function. SE Epiphany Root Canal Sealant has been designed for dual cure capabilities. Device composition is approximately 60-70% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for SE Epiphany Root Canal Sealant is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.

The provided document is a 510(k) summary for a medical device (SE Epiphany Root Canal Sealant) and its FDA clearance letter. It does not describe an AI medical device or a study involving an AI algorithm. Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria.

The document pertains to a dental root canal sealant and its substantial equivalence to a predicate device based on its intended function, composition, and manufacturing process. It's a traditional medical device submission, not one related to AI or algorithmic performance evaluation.

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