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K Number
K040952
Device Name
PRELUDE
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2004-06-29

(78 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K990498,K014027,K990040,K012082
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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

AI/ML Overview

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.

§ 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.