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510(k) Data Aggregation

    K Number
    K170261
    Device Name
    Premium Plus Prophy Air Motor
    Manufacturer
    PREMIUM PLUS INTERNATIONAL LIMITED
    Date Cleared
    2017-10-19

    (265 days)

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

    PREMIUM PLUS INTERNATIONAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.
    Device Description
    Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.
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    K Number
    K163447
    Device Name
    Premium Plus Disposable Barrier Sleeve
    Manufacturer
    PREMIUM PLUS INTERNATIONAL LIMITED
    Date Cleared
    2017-06-20

    (194 days)

    Product Code
    PEM
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREMIUM PLUS INTERNATIONAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premium Plus Disposable Barrier Sleeve is intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
    Device Description
    Premium Plus Disposable Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These barrier sleeves consist of various sizes and shapes which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument travs, x-ray heads, and others. The products are sold nonsterile, prepackaged, and are disposable, single use only.
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    K Number
    K153514
    Device Name
    Premium Plus C01/C02 LED Curing Light
    Manufacturer
    PREMIUM PLUS INTERNATIONAL LIMITED
    Date Cleared
    2016-08-22

    (259 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREMIUM PLUS INTERNATIONAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.
    Device Description
    Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market. Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.
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    K Number
    K100854
    Device Name
    PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
    Manufacturer
    PREMIUM PLUS INTERNATIONAL LIMITED
    Date Cleared
    2010-12-09

    (258 days)

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

    PREMIUM PLUS INTERNATIONAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Premium Plus Disposable Prophy Angle Model 3399 is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient.
    Device Description
    Not Found
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