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510(k) Data Aggregation

    K Number
    K103474
    Device Name
    ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
    Manufacturer
    MICERIUM S.P.A.
    Date Cleared
    2011-02-07

    (73 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICERIUM S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown).
    Device Description
    ENA TEMP/ ENAMEL PLUS TEMP is a system of liquid and powder resin available in different colours, for aesthetic temporary crown and bridge. It can be used both in laboratory (by indirect method: diagnostic waxing up or vacuum forming matrix) and in dental practice (by direct method in the mouth: silicone impression or preformed crown). Please note that the resin is absolutely the same, but they will be sold with two different brand names for commercial reasons. So, in order to simplify, from here on they will be denoted as "Temp"
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    K Number
    K072978
    Device Name
    TENDER ORTHO BOND-ENA BOND-ENA ETCH
    Manufacturer
    MICERIUM S.P.A.
    Date Cleared
    2008-01-17

    (87 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICERIUM S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adhesive for luting ceramic and metal orthodontic brackets
    Device Description
    Adhesive system, light curable both with halogen and LED Light, for brackets cementation. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
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    K Number
    K063170
    Device Name
    TENDER FIBER
    Manufacturer
    MICERIUM S.P.A.
    Date Cleared
    2007-01-12

    (86 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICERIUM S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and rethodontic appliances. It can be use as well to immobilize teeth for periodontic or orthodontic treatments.
    Device Description
    Tender Fiber are silanized glass fibers, impregnated with light curing resin used to reinforce prosthodontic appliances and to repair or reinforce denture and orthodontic appliances.
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    K Number
    K062355
    Device Name
    ENA CEM
    Manufacturer
    MICERIUM S.P.A.
    Date Cleared
    2006-12-27

    (135 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICERIUM S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EnaCem is a dual curing radiopaque fluorescent luting composite, available in several dentine colours, for cementation of posts, ceramic and composite inlay, onlay veneers and crowns. It can be used also for core build-up and as a liner.
    Device Description
    The ENA CEM is a luting material available in a flowable consistency (Ena Cem) and also in a high viscous version (Ena Cem HF) that is available in different colours. Both can be used for cementing prosthesis appliances made in laboratory to the tooth. They can be used also for post-cementation. Ena Cem HF can also be used for core build-up and as a liner. The accessories and try-in materials contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
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    K Number
    K062367
    Device Name
    MINISCREWS ANCHORING SYSTEM, M.A.S.
    Manufacturer
    MICERIUM S.P.A.
    Date Cleared
    2006-12-08

    (116 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICERIUM S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only on adults over the age of 12.
    Device Description
    This device is an endosseous dental implant consisting of the major component, of root-form, screw type, and the accessories, designed to facilitate placing and using the implant in orthodontic procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head (groove) has a aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal hexagon for insertion of the screw driver. The MAS implant is made from Group V titanium.
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    K Number
    K062906
    Device Name
    ENA HFO COMPOSITE SYSTEM
    Manufacturer
    MICERIUM S.P.A.
    Date Cleared
    2006-11-17

    (51 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICERIUM S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENA HFO is a composite system for direct and indirect aesthetic restorations in anterior and posterior sectors.
    Device Description
    ENA HFO is a system for direct and indirect aesthetic restorations in anterior and posterior sectors, composed by a light curing radiopaque composite, available in different colors, with accessories for application and polishing. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
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