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    K Number
    K161051
    Device Name
    All-Bond Universal w/BAC (not finalized)
    Manufacturer
    Bisco, Inc.
    Date Cleared
    2016-09-09

    (148 days)

    Product Code
    KLE,CLA
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K100752,K112118
    Why did this record match?
    Reference Devices :

    K100752

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

    ALL-BOND UNIVERSAL w/BAC adhesive is used for:

    1. all direct restorations
    2. all indirect restorations
    3. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
    4. desensitizing/sealing of tooth structure
    5. protective varnish for glass ionomer fillings
    6. priming of enamel for orthodontic use
    Device Description

    BISCO's ALL-BOND UNIVERSAL w/BAC is a light-cured single-component dental bonding agent that combines etching, priming, and bonding with benzalkonium chloride (BAC) in one bottle. ALL-BOND UNIVERSAL w/BAC is an ethanol/water-based dental adhesive which bonds to dentin and cut and un-cut enamel. ALL-BOND UNIVERSAL w/BAC has been designed to be fully compatible with light-cured and dual-cured composite materials. ALL-BOND UNIVERSAL w/BAC can be used for the bonding of both direct and indirect restorations. ALL-BOND UNIVERSAL w/BAC may be used with or without phosphoric acid etchant.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of the "All-Bond Universal w/BAC" dental adhesive.

    Here's the information requested, extracted and organized:

    1. Table of Acceptance Criteria and Reported Device Performance

    Physical / Mechanical PropertyAcceptance Criteria (Implied by Equivalence to Predicates or ISO Standard)Reported Device Performance (All-Bond Universal w/BAC)
    Bond StrengthEquivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)Equivalent to the primary and reference predicate.
    Moisture ToleranceEquivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)Equivalent to the primary and reference predicate.
    Film ThicknessMeets requirements of ISO 4049:2009 (Predicate values: DREAMBOND: 2.6µm, Peak Universal Bond: 17.0µm)Meets the requirements of ISO 4049:2009 for Film Thickness. (Reported value: 3.4µm, shown in a separate table implying it meets the standard and is comparable to predicates).
    Water Sorption / SolubilityEquivalent to primary predicate (DREAMBOND) based on ADA/ANSI Specification No. 27Equivalent to the primary predicate.
    Immediate Bond StrengthEquivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)Equivalent to the primary and reference predicate.
    Bond Strength DurabilityPerformance comparable to or better than predicates (Reference predicate showed 23% reduction, Primary predicate showed 27% reduction)Showed a 4% increase in bond strength on completion of the test.
    Solvent EvaporationEquivalent to primary and reference predicates (DREAMBOND, Peak Universal Bond)Equivalent to the primary and reference predicate.
    pHEquivalent to primary predicate (DREAMBOND)Equivalent to the primary predicate.
    BiocompatibilityNot toxic (Implied standard based on ISO 7405:2008 and ISO 10993-1)Concluded from the evaluation and the results of the Oral Toxicity Study (10 rats, 7 days) that All-Bond Universal w/BAC was not toxic in this test.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Test Set Sample Size:
      • For Biocompatibility, an "Oral Toxicity Study" used 10 rats.
      • For other physical/mechanical properties (Bond Strength, Moisture Tolerance, Film Thickness, Water Sorption / Solubility, Immediate Bond Strength, Bond Strength Durability, Solvent Evaporation, pH), specific sample sizes are not explicitly stated in the provided text. The testing is described as occurring for "All-Bond Universal w/BAC".
    • Data Provenance: The text does not explicitly state the country of origin or whether the studies were retrospective or prospective. It is implied these are laboratory-based studies conducted by or for the manufacturer (Bisco, Inc. in Schaumburg, IL, USA) for regulatory submission.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • The studies described are physical/mechanical property tests and biocompatibility tests, not studies requiring expert interpretation (like medical imaging). Therefore, there were no human experts establishing "ground truth" in the diagnostic sense. The "ground truth" is established by the standardized testing methodologies (e.g., ISO, ADA/ANSI standards) and measurements of physical properties.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • This concept is not applicable here as the studies are laboratory-based physical and mechanical property tests and animal biocompatibility studies, not studies requiring human adjudication of subjective data. Therefore, none was used.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No MRMC comparative effectiveness study was done. This device is a dental adhesive, not an AI-powered diagnostic tool, so such a study would not be relevant.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • This device is a dental adhesive, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance demonstrated is the standalone performance of the material itself.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • The "ground truth" for the performance of the dental adhesive is based on standardized laboratory testing methods (e.g., modified ISO 29022:2013 for bond strength, ISO 4049:2009 for film thickness, ADA/ANSI Specification No. 27 for water sorption/solubility, and ISO 7405:2008 and ISO 10993-1 for biocompatibility). For biocompatibility, it was specifically an "Oral Toxicity Study" with animal models.

    8. The sample size for the training set

    • There is no training set mentioned or implied, as this is a physical product (dental adhesive), not a machine learning model.

    9. How the ground truth for the training set was established

    • As there is no training set, this question is not applicable.
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