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Halley resin is a light-cured resin indicated for the fabrication of dental laboratories, including full and partial dentures as well as implant overdentures. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.

Halley resin can be utilized as an aid in bonding denture teeth as well as repair using traditional techniques.

Halley Denture-Tooth Bonding Agent is indicated for use in enhancing the bond of denture base.

Halley Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

The proposed device, Halley resin system introduces two additional components (Halley Denture-Tooth Bonding Agent and Halley Sealer) to the Halley resin (K190043) workflow. The proposed Halley resin system consists of light-cured resins that support the modification of the Halley resin (K190043) workflow to include bonding and sealing steps using conventional techniques. The two additional components of the Halley resin system have previously been cleared under Eclipse® Bonding Agent. K051707 and TEMPEX Esthetic Provisional System. K061264. For comparison purposes, the reference device VLC Sealer (part of the TEMPFX Esthetic Provisional System, K061264) is being included. These devices are being included as reference devices (Eclipse® Bonding Agent, K051707 and TEMPFX Esthetic Provisional System, K061264) to support chemical composition and characteristics to support the Halley resin (K190043) workflow.

The provided text describes a 510(k) premarket notification for a dental device, the Halley Resin System. This submission establishes substantial equivalence to a predicate device (Halley resin K190043) and reference devices (Eclipse® Bonding Agent K051707 and TEMPFX Esthetic Provisional System K061264).

Crucially, this document is for a dental resin system, not an AI/ML-driven medical device for diagnosis or prognosis. Therefore, the requested information about acceptance criteria, study types (MRMC, standalone), ground truth establishment, sample sizes for training/test sets, expert adjudication, and effect sizes for human reader improvement with AI assistance do not apply to this submission.

The document discusses non-clinical performance data, specifically physical properties and biocompatibility testing of the resin system components, to demonstrate that the proposed device performs as intended and is safe. It explicitly states that "No data from human clinical studies has been included to support the substantial equivalence of the proposed device, Halley resin system."

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document describes a traditional medical device submission based on material properties and established workflows using existing, cleared components.

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