LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253254

    Validate with FDA (Live)

    Device Name
    GBT Machine Airflow Prophylaxis Master
    Manufacturer
    E.M.S Electro Medical Systems S.A
    Date Cleared
    2026-01-28

    (121 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K190124,K171189
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K190124, K190124, K190124, K171189

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GBT Machine AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis.

    The GBT Machine AIRFLOW Prophylaxis Master is intended for use in the following dental and periodontal applications:

    • Removing supra and subgingival calculus deposits and stains from teeth
    • Periodontal pocket lavage with simultaneous ultrasonic tip movement
    • Scaling and root planing

    The GBT Machine 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 GBT Machine 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 GBT Machine AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The GBT Machine AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

    Device Description

    The GBT Machine AIRFLOW® Prophylaxis Master is a dental device that combines ultrasonic scaling and air-polishing functions into a single integrated system. It is a modified version of the AIRFLOW Prophylaxis Master previously cleared under 510(k) K190124. The device is compatible with EMS ultrasonic scaling instruments cleared under 510(k) K190124 and with prophylaxis powders including AIRFLOW CLASSIC (K190124), AIR-FLOW PERIO (K190124), and AIR-FLOW PLUS (K171189).

    The device is composed of a central control unit, interchangeable handpieces (PIEZON, AIRFLOW, and PERIOFLOW), powder chambers, an irrigation system, and a wireless Bluetooth foot pedal. The control unit contains the power supply, ultrasonic generator, powder and fluid delivery circuits, and a microprocessor control system.

    Treatment is activated via the wireless foot pedal, and the control panel allows the clinician to adjust power and irrigation levels. The ultrasonic scaling function operates in the 24-32kHz range using piezoelectric vibration to remove calculus and stains, while the air-polishing function sprays a mixture of air, water, and powder for supragingival and subgingival cleaning.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1