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510(k) Data Aggregation

    K Number
    K973397
    Device Name
    SYNTAC SPRINT
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1997-11-21

    (73 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Syntact Sprint™ is used as an adhesive for direct light curing composite and compomer restorations.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental adhesive product called "Syntac Sprint." This document does not contain information about acceptance criteria or a study proving the device meets them. It is a regulatory approval letter.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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