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510(k) Data Aggregation

    K Number
    K190124
    Device Name
    EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
    Manufacturer
    E.M.S Electro Medical Systems S.A.
    Date Cleared
    2019-10-20

    (268 days)

    Product Code
    ELC, KOJ
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    E.M.S Electro Medical Systems S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental applications: - · Removing supra and subgingival calculus deposits and stains from teeth - · Periodontal pocket lavage with simultaneous ultrasonic tip movement - · Scaling and root planing - · Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha - Plugging for amalgam condensation - Amalgam burnishing - · Preparing, cleaning and irrigating root canals - · Cavity preparation - · Cementing inlays and onlays - · Retrograde preparation of root canals The AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. The AIRFLOW Prophylaxis Master can be used for the following cleaning procedures: - · plaque removal for placement of sealants - · surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers - · surface preparation prior to placing composite restorations - · effective plaque and stain removal for orthodontic patients - · cleaning prior to bonding ortho brackets - cleaning implant fixture prior to loading - · stain removal for shade determination - · plaque removal prior to fluoride treatment - · plaque and stain removal prior to whitening procedure The AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment. The AIRFLOW One is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. The AIRFLOW One can be used for the following cleaning procedures: - · plaque removal for placement of sealants - · surface preparation prior to bonding/cementation of inlays, crowns and veneers - · surface preparation prior to placing composite restorations - effective plaque and stain removal for orthodontic patients - · cleaning prior to bonding ortho brackets - · cleaning implant fixture prior to loading - · stain removal for shade determination - · plaque removal prior to fluoride treatment - · plaque and stain removal prior to whitening procedure The AIRFLOW One is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
    Device Description
    The EMS AIRFLOW Prophylaxis Master is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of a control unit, hoses, handpiece cords for the two handpieces and a foot pedal which can be wired or wireless. There are two repositories on the control unit: one for the irrigation liquid container or the waterline cleaner container and the other one for one of both air-polishing powder chambers supplied with the device. The AIRFLOW Prophylaxis Master is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures. The AIRFLOW Prophylaxis Master is also supplied with the AIR-FLOW Handpiece and optionally with the PERIO-FLOW Handpiece and the PERIO-FLOW Nozzles marked for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC new formula (sodium bicarbonate), AIR-FLOW SOFT (glycine), AIR-FLOW PERIO (glycine) and AIR-FLOW PLUS (Erythritol) prophylaxis powders. The AIRFLOW Prophylaxis Master is supplied with accessories for attaching and removing instruments and nozzles from the handpieces. The EMS AIRFLOW One is the same device as the EMS AIRFLOW Prophylaxis Master without the ultrasonic scaling function. Therefore, the description of the AIRFLOW Prophylaxis Master is also applicable to the AIRFLOW One, except the part related to the ultrasonic scaling function.
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