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510(k) Data Aggregation

    K Number
    K012673
    Device Name
    PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
    Manufacturer
    PRIME DENTAL MANUFACTURING, INC.
    Date Cleared
    2001-10-24

    (71 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

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

    Prime-Dent® One-Step Orthodontic Adhesive Bonding System is a resin/paste system intended for bonding plastic, metal or ceramic orthodontic brackets to etched enamel. An active archwire may be placed immediately after adhesive has properly cured.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental adhesive bonding system, which primarily confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance. It does not contain details of a clinical study or performance data that would answer your questions.

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