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510(k) Data Aggregation

    K Number
    K980672
    Device Name
    SIMPLEX AIRBRATOR (SAB-7)
    Date Cleared
    2000-05-04

    (804 days)

    Product Code
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRT MANAGEMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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    K Number
    K980783
    Device Name
    SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5
    Date Cleared
    1998-04-21

    (50 days)

    Product Code
    Regulation Number
    872.6050
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRT MANAGEMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    General Usage: For the absorption/Collection and removal of excessive saliva during dental procedures. For the absorption/Collection and removal of saliva when excessive saliva is seen collecting in the mouth. For the absorption/Collection and removal of saliva in General Pediatric Use. For the absorption/Collection and removal of saliva whenever a potential choking hazard exists with commonly used saliva absorbers. For the absorption and removal of saliva when typical "suction" type devices are not appropriate or effective. ... For the collection of saliva when other absorber devices or suction devices are not appropriate or tolerated easily by the patient.
    Device Description
    SIMPLEX™ SALIVA ABSORBER/COLLECTOR
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