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510(k) Data Aggregation

    K Number
    K980672
    Device Name
    SIMPLEX AIRBRATOR (SAB-7)
    Manufacturer
    IRT MANAGEMENT CORP.
    Date Cleared
    2000-05-04

    (804 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

    General Usage: Cleaning of Tooth Surfaces Stain Removal from Tooth Surfaces Removal of Surface Deposits from Toeth Cleaning of Dental Pits and Fissures Microciching of enamel and dentin surfaces in preparation for adhesive bonding procedures Microciding of enamer and deching and etching) of metallic, ceramic, composite and actylic surfaces for dental procedures including bonding, cementation, repair and restoration Delivers a controlled stream of particles for the removal of tooth structure Specific Dental Usage: Preparation of tooth surfaces for sealants Preparation of tooth surfaces for orthodontic bracket bonding Preparation of tooth surfaces for bonding bridges Preparation of internal root surfaces for post procedures (after root canal therapy) I reparation of tooth surfaces for adhesive bonding procedures, ceramic inlays, crowns and bridges Preparation of root surfaces for periodontal procedures Repair of composite, acrylic and ceramic restorations Occlusal adjustments and equilibration Repair of prosthetic appliances Bonded splint procedures Removal of cement from temporary and permanent procedures Class I-V cavity preparation NOT FOR USE ON AMALGAM

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the BioStar Airbrator (trade name SIMPLEX™ AIRBRATOR™). It primarily lists the device's intended uses and confirms its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

    Therefore, I cannot provide the requested information from this document.

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