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    K Number
    K061998
    Device Name
    PREMIER SELF-ETCHING BOND ENHANCER
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2006-10-04

    (82 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PREMIER SELF-ETCHING BOND ENHANCER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents. When used with dental bonding agents, Premier Self-Etching Bond Enhancer can be used for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up material and for bonding veneers, onlays and inlays.

    Device Description

    Premier Self-Etching Bond Enhancer is a no-rinse multi-purpose adhesive primer and bond coupling agent designed to work with existing bonding agents.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental bonding agent. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic devices.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size. This type of information is typically found in clinical study reports or performance data sections of 510(k) submissions, which are not included in this regulatory letter.

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