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510(k) Data Aggregation

    K Number
    K123824
    Device Name
    VITRO FIL LC
    Date Cleared
    2013-02-21

    (71 days)

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

    DFL INDUSTRIA E COMERCIO S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - As a structural reinforcement for fabricating and/or repairing Class III and Class V restorations - Restoration of root surface caries - Restorations of cervical erosions - Small Class I restorations - Primary teeth restoration - Core build up - Liner
    Device Description
    Virto Fil LC is a dental cement that is composed of varoius materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges or to be applied to a tooth to protect the tooth pulp. Vitro Fil LC is a resin modified glass ionomer base cement used as a temporary tooth filling. Vitro Fil LC offers a strong bonding of the ionomer to the tooth. The glass ionomer offers high chemical adhesion, fluoride release and biocompatibility. Vitro Fil LC is for permanent cementation.
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    K Number
    K123826
    Device Name
    VITRO MOLAR
    Date Cleared
    2013-02-14

    (64 days)

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

    DFL INDUSTRIA E COMERCIO S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Class I, Class II, Class III and Class V restorations . - Non-bearing Class I and Class II restorations in permanent teeth . - Intermediate restoration for heavy stress situations in Class I and Class II . cavities - Core build up . - Liner .
    Device Description
    Vitro Molar is a condensable, chemically activated glass ionomer cement, used in restorations of posterior teeth; it is radiopaque and offers good esthetic properties, easy manipulation, fast curing and it can be easily sculpted. It hardens via an acid/base reaction. Vitro Molar is also highly resistant to compression and bending, and has a hard, low-abrasive surface. It is ideal to be used in the atraumatic restorative treatment (ART) technique. Vitro Molar is for permanent cementation.
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