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510(k) Data Aggregation

    K Number
    K130534
    Device Name
    DIPLOMAT
    Date Cleared
    2013-10-30

    (243 days)

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

    DIPLOMAT DENTAL S.R.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
    Device Description
    Diplomat dental operative units are modern, ergonomically designed, dental systems offered in a wide range of models depending on the specific end user requirements. Diplomat dental operative units are AC-powered devices that are intended to supply power to, and serve as a base for, other dental devices and accessories - such as hand-pieces, operating lights, curing lights, ultrasonic instruments, hygiene instruments, etc. - and deliver electric, air, water and vacuum power to them. Diplomat dental operative units are offered either with the patient dental chair or as a free-standing unit without the chair for those end-users with existing patient chairs that they want to use.
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