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510(k) Data Aggregation

    K Number
    K964525

    Validate with FDA (Live)

    Device Name
    PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    1997-01-22

    (71 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K942493,K962348
    Predicate For
    K122522,K974486,K982394,K990040
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent is a one-component, no-mix visible light curable dental bonding agent that contains fluoride. A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime & Bond" 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner to use self-cure bonding techniques for the current Indications for Use of the Bonding Agent where a dual-cured adhesive may be desired. Also because of the self-cure capability, use of the Bonding Agent and Activator cogether allows adhesion of amalgam restorations to tooth structures, which is a NEW INDICATION FOR USE.

    Device Description

    Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent is a one-component, no-mix visible light curable dental bonding agent that contains fluoride. No changes have been made to Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent in design, material, chemical composition or manufacturing process. A new accessory, Prime & Bond™ Self-Curing Activator, can be used with Prime & Bond" 2.1 Multipurpose Dentin/Enamel Bonding Agent, enabling the practitioner to use self-cure bonding techniques for the current Indications for Use of the Bonding Agent where a dual-cured adhesive may be desired. Prime & Bond™ Self-Curing Activator is an acetone/ethanol solution of an aromatic sulfinic acid salt. When applied in combination with Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent, the Activator initiates a self-cure, free radical polymerization of the monomers and oligomers present in the Prime & Bond™ 2.1 Multipurpose Dentin/Enamel Bonding Agent.

    AI/ML Overview

    This 510(k) submission describes a dental bonding agent and an activator. However, it does not contain the detailed information required to fulfill the request concerning acceptance criteria and the specifics of a study proving device performance on a test set. This document is a summary for a regulatory submission, not a detailed study report. It states that "performance data presented for the use of Prime & Bond® 2.1 Multipurpose Dentin/Enamel Bonding Agent with the Prime & Bond Self-Curing Activator" was included, but the actual performance data and study details are not provided in this 510(k) summary.

    Therefore, I cannot provide the requested information from the given text. The provided text is a high-level summary for a 510(k) submission and lacks the specific details about studies, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.

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