Z BOND, PRELUDE ONE

• K Number: K111876
• Device Name: Z BOND, PRELUDE ONE
• Manufacturer: DANVILLE MATERIALS, INC.
• Date Cleared: 2011-09-21 ( 82 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Z Bond and Prelude One are a Primer and adhesive used for:

• Conditioning of zirconia, alumina, and metal definitive restorations prior to cementation, . e.g., crowns, posts, inlays, and onlays.
• Adhesive repair of defects in zirconia, alumina, metal and composite restorations . currently affixed to a patient's dentition.
• . Adhesive for bonding composites and other dental restorative materials to enamel or dentin.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter and "Indications for Use Form" from the FDA concerning dental bonding agents (Z Bond and Prelude One).

It does not contain information about:

• Acceptance criteria for a device performance study.
• Details of a study proving device meets acceptance criteria (experimental design, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

Therefore, I cannot fulfill your request based on the provided text.

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.