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510(k) Data Aggregation

    K Number
    K131734
    Device Name
    ALL-BOND UNIVERSAL SC (NOT FINALIZED)
    Manufacturer
    BISCO, INC.
    Date Cleared
    2014-04-11

    (302 days)

    Product Code
    KLE,CLA
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K063780
    Why did this record match?
    Device Name :

    ALL-BOND UNIVERSAL SC (NOT FINALIZED)

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

    All-Bond Universal SC adhesive is used for:

    • Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core build-ups)
    • Indirect Restorations (e.g. metal, glass, ceramics, zirconia/alumina)
    • Bonding Resin or Primer for Substrates
    • Desensitization/Sealing of Tooth
    • Intraoral Repair (e.g. chipped porcelain, additions to direct restorations)
    Device Description

    All-Bond Universal SC is an auto-polymerizing adhesive with a light-curing alternative. It is designed for the dentist who prefers not to light cure the adhesive layer under indirect restorations. All-Bond Universal SC has a low film thickness (

    AI/ML Overview

    The provided text is a 510(k) summary for a dental adhesive, "All-Bond Universal SC," indicating its substantial equivalence to a predicate device, "ACE Bond SE." The summary focuses on chemical composition, physical/mechanical properties, and biocompatibility rather than clinical performance based on a test set and ground truth in the way one might expect for an AI/CADe device. Therefore, many of the requested categories about acceptance criteria, study design for a test set, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as it describes a traditional dental adhesive, not a diagnostic or AI-powered medical device.

    However, I can extract the information that is present and indicate where the requested information is not available in the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Predicate Device Performance)Reported Device Performance (All-Bond Universal SC)
    Light-CuredX (Present)X (Present)
    Auto-PolymerizingX (Present)X (Present)
    Unfilled, multifunctional methacrylate resinX (Present)X (Present)
    Ethanol basedX (Present)X (Present)
    Two component adhesiveX (Present)X (Present)
    Color Changes from pink to clear after cureX (Present)--- (Not Present)
    Solvent Based Formulation (solvent>40% by weight)X (Present)X (Present)
    Self-Etching Dental AdhesiveX (Present)X (Present)
    Total-Etching Dental AdhesiveX (Present)X (Present)
    Film ThicknessModified technique from ISO 4049`
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