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510(k) Data Aggregation

    K Number
    K030977
    Device Name
    DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
    Manufacturer
    DENTAURUM
    Date Cleared
    2003-08-25

    (150 days)

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

    DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE

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

    Dentaurum MIX Two-paste Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

    Device Description

    Dentaurum MIX Two-paste Bracket Adhesive

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental adhesive. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that you've requested.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results.

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