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PeriAcryl® 90, PeriAcry18 80, PeriAcry1 70, and PeriAcry16 60 are indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.

The Family of PeriAcryl® is a formulated compound of the cyanoacrylate series. It is available in 90/10 butyl/octyl, 80/20, butyl/octyl, 70/30 butyl/octyl and 60/40 butyl/octyl formulations depending on the dentist's preference. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.

This submission for KO71484 is for a medical device (PeriAcryl®), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (like MRMC studies, standalone performance, training sets, etc.) is not applicable to this document.

The document describes the device as a formulated compound of the cyanoacrylate series, indicated as an adjunct to temporarily assist in securing periodontal dressings. The substantial equivalency information states that the device has the same intended use and technological characteristics as predicate devices and does not contain new ingredients raising additional safety and effectiveness concerns.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as these concepts are inherent to the evaluation of AI/ML software performance, which is not the subject of this 510(k) summary.

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