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510(k) Data Aggregation

    K Number
    K031851
    Device Name
    DENTISEPTIC HPC
    Manufacturer
    Date Cleared
    2003-08-01

    (46 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    BETHEL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DentaSeptic HPC device is intended as a single use, disposable, transparent, plastic, disposable, non-sterile protective cover to be placed over various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover acts as a physical barrier that assists in providing surface protection for the handpieces, reducing cross contamination of equipment, augmenting existing infection control techniques and making clean up and disinfection less time consuming.
    Device Description
    The DentaSeptic HPC device is a disposable plastic cover that is made of high density polyethylene (HDPE), that fits over the ends of various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover allows for the attachment and/or protrusion, where applicable, of those parts of the devices that are inserted into the patient's mouth.
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