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510(k) Data Aggregation

    K Number
    K150392
    Device Name
    PROPEL device
    Date Cleared
    2015-09-18

    (212 days)

    Product Code
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROPEL ORTHODONTICS LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.
    Device Description
    The PROPEL Device is intended for use in dental operative procedures involving the preparation of tissue and bone. The PROPEL Device can be used manually as a bone cutting instrument in accordance with the FDA regulation 21 CFR Sec. 872.4120. It CANNOT be attached to any powered driver. The PROPEL Device has a stainless steel drill tip that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth at 3. 5. or 7mm, thus preventing the drill tip from penetrating the bone bevond the targeted depth when used during orthodontic and dental operative procedures. The handle contains a red LED. operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved. The device is provided sterile and is for single use only.
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