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510(k) Data Aggregation

    K Number
    K213742
    Device Name
    Infinity Pro, Logic, Quality, Sprint
    Date Cleared
    2022-10-19

    (324 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Olsen Indústria e Comércio S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Infinity Pro, Logic, Quality, Sprint are in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, electricity, and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
    Device Description
    The Olsen dental units consist of a patient chair, foot control, dentist element, water unit and a dental operating light. The Olsen dental units also include coupling for various handpieces and accessories that can be added to the Olsen Dental System such as pneumatic handpieces, handpieces with generator, optical fiber handpieces, pneumatic scalers, air/water syringes, SE (saliva ejectors) and handpieces for vacuum. None of the Olsen dental units, parts or accessories are provided sterile. Infinity Pro, Logic, Quality and Sprint Dental Systems serves as a base that includes components to deliver air, water, electricity, and vacuum to dental handpieces instruments.
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