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510(k) Data Aggregation
K Number
K110403Device Name
PROLINK ADHESIVES (PROLINK, PROLINK SE)
Manufacturer
SILMET LTD.
Date Cleared
2011-09-08
(209 days)
Product Code
KLE
Regulation Number
872.3200Why 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
K103190Device Name
PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
Manufacturer
SILMET LTD.
Date Cleared
2011-02-02
(97 days)
Product Code
EBF
Regulation Number
872.3690Why 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
K101869Device 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
872.3275Why 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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