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510(k) Data Aggregation

    K Number
    K161684
    Device Name
    Quantum LB
    Manufacturer
    Reliance Orthodontic Products Inc.
    Date Cleared
    2016-10-06

    (111 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K880393
    Why did this record match?
    Device Name :

    Quantum LB

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

    This Device is intended for use as a light cure, orthodontic adhesive.

    Device Description

    This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.

    AI/ML Overview

    The provided text describes a 510(k) submission for the "Quantum LB" orthodontic adhesive. The study aims to demonstrate substantial equivalence to a predicate device, Transbond XT.

    Here's an analysis of the acceptance criteria and the study presented:

    Quantum LB Orthodontic Adhesive - Acceptance Criteria and Study Details

    1. Acceptance Criteria and Reported Device Performance

    The core acceptance criterion for the Quantum LB device, as per the provided summary, is similar performance to the predicate device (Transbond XT) in shear bond strength. No specific numerical thresholds are given for this similarity, but the summary states it was achieved.

    PropertyAcceptance Criteria (Implied)Reported Device Performance (Quantum LB)
    In-vivo Shear Bond StrengthSimilar to Transbond XT"Testing resulted in similar performance between the two adhesives."
    Biocompatibility (Local/Systemic Effects)No adverse effects"determined to not directly or through the release of material constituents produce adverse local or systemic effects."
    Cytotoxicity (ISO 10993-5 Elution Method)Grade
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