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510(k) Data Aggregation

    K Number
    K964755
    Device Name
    MICROJET CAVITY PREPARATION SYSTEM
    Manufacturer
    MIDWEST DENTAL PRODUCTS CORP.
    Date Cleared
    1997-09-11

    (288 days)

    Product Code
    KOJ,DAT
    Regulation Number
    872.6080
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations. MicroJet System is intended as an ancillary device for removing tooth structure, and restorative dental materials as well as preparing teeth for dental restoration.

    Device Description

    MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations.

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a dental device, the Microjet Cavity Preparation System. It is not a study report and therefore does not contain the detailed information requested regarding acceptance criteria and study results.

    The letter confirms that the device is "substantially equivalent" to devices marketed prior to 1976. This determination is based on a 510(k) submission, which typically involves demonstrating equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be found in a research paper.

    Therefore, I cannot provide the requested information based on the provided text.

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