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510(k) Data Aggregation

    K Number
    K110403
    Device Name
    PROLINK ADHESIVES (PROLINK, PROLINK SE)
    Manufacturer
    SILMET LTD.
    Date Cleared
    2011-09-08

    (209 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILMET LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProLink: Direct Composite or Compomer restorations, Adhesive cementation, Composite repair. ProLink SE: Bonding of composites to tooth structure, Core Build up, Adhesive cementation of crown & bridges, including inlays and onlays.
    Device Description
    ProLink is a 5th generation dentin/enamel single step bonding agent. The primer and adhesive are combined into a single component for ease of application. ProLink delivers outstanding shear bonding values to dentin, enamel & all popular light, dual or auto-cure composites. ProLink SE is a 7th generation light cured self etching dentin/enamel bonding agent. The etch, primer and adhesive are combined into a single component for ease of application. Separate conditioning (etching) of the enamel and dentine is not required.
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    K Number
    K103190
    Device Name
    PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
    Manufacturer
    SILMET LTD.
    Date Cleared
    2011-02-02

    (97 days)

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

    SILMET LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProFil: Direct anterior & posterior restorations, Core Build ups, Splinting. ProFil Flow: Class III, V & smaller Class IV restorations, Base/liner in Class I & Class II restorations, Repair resin, porcelain & acrylic temporary materials, Pit & fissure sealant, Undercut blockout, Restoration of minimally invasive cavity preparations.
    Device Description
    The ProFil Composites are light cured restorative micro hybrid composite resins for use in both posterior and anterior restorations. The restoratives are available in a variety of tooth colored shades and are packaged in syringes and capsules.
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    K Number
    K101869
    Device Name
    PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
    Manufacturer
    SILMET LTD.
    Date Cleared
    2010-09-29

    (89 days)

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

    SILMET LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProGlass One: Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges; Cementation of orthodontic bands; Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns; Base/liner ProGlass Two: Class III, V and limited class I cavities; Restoration of primary teeth; Core Build Up ProGlass Two LC: Class III and V restorations; Restoration of Cervical erosions and root surface caries; Core Build Up; Base/Liner ProGlass Nine: Class I & II cavities; Decidious teeth: final restorative for Class I, II and V; Long term restorative in non-load bearing areas of Class I, II and V; Intermediate restorative & sandwich material for heavy stress bearing; Core build up material ProGlass Plus: Metal-based restorations; Ceramic inlays; Reinforced ceramic crowns and bridges; All kinds of acrylic/resin crowns, inlays, onlays and bridges ProGlass Silver: Class I, limited Class II, temporary fillings; Restoration of primary teeth; Core Build Up; Base/Liner
    Device Description
    The ProGlass cements are classified as a Dental Cement (21 C.F.R. part 872.3275) because they are devices composed of various 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.
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