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510(k) Data Aggregation

    K Number
    K974014
    Device Name
    PULPDENT DENTASTIC UNO
    Manufacturer
    PULPDENT CORP.
    Date Cleared
    1997-12-17

    (56 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K926074,K931710,K953272,K953301
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K926074, K931710, K953272, K953301

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

    Pulpdent DenTASTIC UNO is a single component dental adhesive primer and bond enhancer used by the dental professional to bond to dentin, enamel, metals and resins.

    Device Description

    Pulpdent DenTASTIC UNO is a single component dental adhesive primer and bond enhancer used by the dental professional to bond to dentin, enamel, metals and resins. The formula for Pulpdent DenTASTIC UNO is similar to that for Pulpdent Bond Enhancer [K926074. K931710. K953272. K953301] which was developed by the American Dental Association Health Foundation. The products are manufactured under license from that organization.

    AI/ML Overview

    This request cannot be fulfilled as the provided document {0} - {3} does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission summary for a dental adhesive, focusing on its substantial equivalence to predicate devices and general safety information, not specific performance metrics or clinical study details as requested.

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