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510(k) Data Aggregation

    K Number
    K193447
    Device Name
    Vista Dyes
    Manufacturer
    Inter-Med / Vista Dental Products
    Date Cleared
    2020-03-11

    (89 days)

    Product Code
    LFC
    Regulation Number
    872.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inter-Med / Vista Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A visual aid for the identification of carious dentin.
    Device Description
    Vista Dyes are colored agents that when applied to the suspected carious areas of the tooth stains the carious dentin. The method of operation and placement of Vista Dyes are similar to that of the primary predicate and reference device, Caries Finder (K955445) and Pulpdent Snoop (K964430), respectively. A drop of the dye is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the carious cavity.
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    K Number
    K193389
    Device Name
    Vista Clear
    Manufacturer
    Inter-Med / Vista Dental Products
    Date Cleared
    2020-03-04

    (89 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inter-Med / Vista Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vista Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista Clear facilitates the insertion of the cord into the sulcus.
    Device Description
    Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.
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    K Number
    K190220
    Device Name
    Vista FS, Vista FS Liquid
    Manufacturer
    Inter-Med / Vista Dental Products
    Date Cleared
    2019-06-10

    (125 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inter-Med / Vista Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vista FS and Vista FS Liquid are intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista FS Liguid facilitate the insertion of the cord into the sulcus.
    Device Description
    Vista FS and Vista FS Liquid are medical devices used to facilitate sulcus retraction prior to taking a dental impressions of a tooth. This entails placement of the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject devices facilitate the insertion of the cord into the sulcus while also facilitating the creating of a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.
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    K Number
    K170101
    Device Name
    Valiant Curing Light
    Manufacturer
    Inter-Med / Vista Dental Products
    Date Cleared
    2017-06-08

    (148 days)

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

    Inter-Med / Vista Dental Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Source of illumination for curing photo-activated dental restorative materials and adhesives.
    Device Description
    The Valiant Curing Light is a visible light activator for polymerization of dental materials and adhesives, such as dental resins and composites. The Valiant Curing Light is composed of a cordless handpiece, a charging base, disposable barrier sleeves, a light attenuating shield, and an instruction for use. The cordless handpiece is made of medical grade aluminum, electronic elements, glass lenses, and medical grade plastic elements. A plastic rotation switch provides an interface to switch between various modes of the cordless handpiece. Once a mode is selected, an ON/OFF button activates and executes the selected mode. The unit is battery operated and contains a removable and rechargeable Li ion battery. The charging base allows for placement and inductive charging of the handpiece when not in use. The light attenuating shield absorbs emitted light from the cordless handpiece to minimize ocular radiation to the patient and user. The Valiant Curing Light is provided non-sterile. Disposable barrier sleeves (510(k) number K132953, TIDI Shield, Model 21102, by TIDI Products) assist in mitigating patient contamination; additionally, the handpiece, charging base and light attenuating shield can withstand common surface disinfectants. Also included in the Valiant Curing Light is an instructions for use. The instructions for use details the function and four independently operable settings of the device: 1) standard curing mode, 2) ramp curing mode, 3) boost curing mode, and 4) white light mode (visualizing of dental anatomy). The white light mode can be used for intraoral illumination to aid in the visualization of dental anatomy (i.e. equivalent to a class I dental operating light, CFR 872.4630). The curing light modes 1-3 provide broad spectrum blue light (400 - 500mm, with peaks at 410nm and 475nm) to cure a variety of dental restorative materials and adhesives utilizing the most common photoinitiators (CQ and PPD). The white light mode 4 provides an aid for illuminating dental anatomy.
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