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510(k) Data Aggregation

    K Number
    K021503
    Device Name
    UNINHIBITED
    Manufacturer
    BISCO, INC.
    Date Cleared
    2002-08-01

    (84 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K882915
    Why did this record match?
    Device Name :

    UNINHIBITED

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

    TO SEAL THE SURFACE OF:

    DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLILNTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS

    Device Description

    UNINHIBITED contains Hexafunctional Urethane Acrylate (30.6%), Polyethylene Glycol (400) Diacrylate (61.4%), phosphine oxide, diphenyl (Photoinitiator) 8.0% 4-methyl methacrylate (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration.

    AI/ML Overview

    The provided text does not contain information on acceptance criteria, device performance, sample size, ground truth establishment, or details about a study to prove the device meets acceptance criteria. The document is a 510(k) premarket notification for a dental sealant called "UNINHIBITED," establishing its substantial equivalence to a predicate device ("Fortify"). It details the device description, intended use, and a comparison table with the predicate device, but no performance studies or specific acceptance criteria are mentioned beyond biocompatibility.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and data provenance
    3. Number of experts used to establish ground truth and their qualifications
    4. Adjudication method
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
    6. If a standalone performance study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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