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XENO® ADHESIVE WITH ACTIVATOR is indicated for:

• direct, light-cured composite and compomer restorations; .
• indirect restorations; .
• light-cured resin cemented veneers; .
• composite, ceramic, and amalgam repairs; .
• cavity varnish for use with fresh amalgam; .
• Cavity varmsil for asself-cure composite restorations and core build-ups; .
• unfect, dual-cure of sen care compoon and bridge retainers, and endodontic post . cementation; and .
• adhesive bonding of direct amalgam restorations. .

XENO® ADHESIVE WITH ACTIVATOR is a dual-cure, self-etch, two-component adhesive system. It utilizes the same XENO® adhesive found in the predicate (wo-component activator found in the Prime & Bond® NT™ adhesive system. When the selfand the same actrator roans in me on with the self-cure activator, it forms an adhesive layer that bonds to self-curing cements.

The provided document is a 510(k) premarket notification for a dental adhesive. It details the device description, intended use, technological characteristics, and regulatory correspondence. However, it does not contain information about acceptance criteria, specific study results, sample sizes for test/training sets, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting detailed performance study data against defined acceptance criteria.

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