LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974488
    Device Name
    AIRPREP SYSTEM - MODEL 9001
    Manufacturer
    ASI MEDICAL, INC.
    Date Cleared
    1998-05-26

    (181 days)

    Product Code
    KOJ
    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

    The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.

    Device Description

    The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing.

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the "Airprep System - Model 9001" and does not contain the detailed study information, acceptance criteria, or performance data typically included in a clinical study report. The letter indicates that the device has been determined to be substantially equivalent to previously marketed devices.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a scientific study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1