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Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.

Prelude is a dental bonding agent used to restore all classes of cavities.

The provided document is a 510(k) summary for a dental bonding agent called "Prelude" and does not contain the detailed study information typically found in acceptance criteria and performance reports for medical devices, particularly those involving AI or complex performance metrics. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the information given. This type of regulatory submission for a dental bonding agent does not involve clinical studies with human readers, ground truth analysis, or AI performance metrics as would be seen for imaging or diagnostic AI devices.

The document mainly covers:

• Device Name: Prelude
• Applicant: Danville Materials, Inc.
• Contact Person: Craig R. Bruns
• Date of Summary: March 12, 2004
• Device Description: A dental bonding agent used to restore all classes of cavities.
• Predicate Devices: Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040), and Optibond Solo Plus Activator (K012082).
• Intended Use/Indications for Use: Light cured adhesive for direct restorations (composites and compomers to enamel/dentin, composite repairs, porcelain repairs, post and core build-up materials) and indirect restorations (veneers, onlays, inlays, crowns, bridges). Can be used with self or dual cure materials when combined with Prelude Activator.

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