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K Number
K070538
Device Name
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
Manufacturer
DENTSPLY INTL.
Date Cleared
2007-03-14

(16 days)

Product Code
KLE
Regulation Number
872.3200
Type
Special
Panel
DE
Reference & Predicate Devices
K050386
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

XP BOND is indicated for

  1. Direct, Light-cured composite and compomer restorative.
  2. Indirect Restorations; Light-cured, resin cemented Veneers.
  3. Composite, ceramic and amalgam repairs.
  4. Cavity varnish for use with fresh amalgam.
  5. Direct, dual cure or self-cure composite restorations and core build-ups.
  6. Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers.
  7. Dual cured and self cured resin cemented Endodontic post cementation.
  8. Adhesive bonding of direct amalgam restoration.
Device Description

The XP BOND Dual Cure is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document is a 510(k) summary for a dental adhesive named "XP BOND Dual Cure Universal Total Etch Adhesive." It details the device description, intended use, technological characteristics, and its substantial equivalence to a predicate device.

Specifically, the document states:

  • "All of the components found in XP BOND have been used in legally marketed devices and were found safe for dental use."
  • "XPBOND has been evaluated and passed biocompatibility testing for Cytotoxicity, Ames Test."
  • "We believe that the prior use of the components of XP BOND in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of XP BOND for the indicated uses."

This indicates that the safety and effectiveness determination for this dental adhesive is based on:

  1. Prior use of its components in legally marketed devices.
  2. Biocompatibility testing.
  3. General "performance data provided" (the specifics of which are not detailed in this summary).

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or other details related to a study for an AI/ML device. This document does not describe such a device or study.

§ 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.