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510(k) Data Aggregation

    K Number
    K213609
    Device Name
    NOVA RESIN dual cure, self adhesive resin cement
    Manufacturer
    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
    Date Cleared
    2022-08-09

    (267 days)

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

    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nova Resin dual cure, self adhesive resin cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers. * Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants. * Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.
    Device Description
    Resin Cement dual cure, self adhesive resin cement for the cementation of indirect restorations made of high strength all ceramic, composite, metal-ceramic and metal. When Resin Cement dual cure, self adhesive resin cement is used, additional bonding agents are not required. The automix double syringe enables saving time direct application of the luting cement into restoration.
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    K Number
    K210473
    Device Name
    Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
    Manufacturer
    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
    Date Cleared
    2021-11-02

    (258 days)

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

    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nova Glass L: -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 Nova Glass F: -Class III, V and limited class I cavities -Restoration of primary teeth -Core Build Up Nova Glass LC: -Class III and V restorations -Restoration of Cervical erosions and root surface caries -Core build up -Base/liner Nova Glass BF: -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 Nova Glass L Plus: -Metal-based restorations -Ceramic inlays -Reinforced ceramic crowns and bridges -All kinds of acrylic/resin crowns, inlays, onlays and bridges
    Device Description
    - Nova Glass Cements are devices intended to serve as a temporary tooth filling or as a base ● cement to affix a temporary tooth filling. - . Nova Glass Cements are based on the reaction of silicate glass powder and polyalkeonic acid. (acid-base reaction) - . Nova Glass Cements are formulated to provide a powder and a liquid portion. In use the two are combined and a chemical reaction takes place to provide set cement.
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    K Number
    K192913
    Device Name
    R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
    Manufacturer
    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
    Date Cleared
    2021-01-19

    (462 days)

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

    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. Direct restorations using light-cured composite resin - 2. Cavity sealing as a pretreatment for indirect restorations - 3. Treatment of exposed root surfaces - 4. Treatment of hypersensitive teeth - 5. Intraoral repairs of fractured restorations - 6. Post cementation and core build-ups - 7. Cementation of inlays, onlays, crowns, bridges and veneers
    Device Description
    R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive. It can be used reliably in total-etch or selective-etch mode for both direct and indirect restorations. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching procedures. The product is intended to be used for both direct and indirect restorations. The 4-MET RDX multi-functional carboxylate methacrylate polymer creates a 3-dimensional, high-strength bond with calcium. MDP (Methacryloyloxydecyl Dihydrogen Phosphate) monomer binds to Ca+2 ions on all surfaces of the tooth. The R&D Series Nova Compo- B Plus forms a micro-mechanical bond between the dentine channels to form the resin tags. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures.
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    K Number
    K192178
    Device Name
    R&D Series Nova Compo N
    Manufacturer
    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
    Date Cleared
    2019-12-20

    (130 days)

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

    Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite for anterior restorations. It is intended for professional use by below mentioned Indications for Use; - · Restorations of deciduous teeth - · Splinting of mobile teeth - · Restoration in the posterior region (Classes I and II) - · Anterior restorations (Classes III, IV) - · Class V restorations (cervical caries, root erosion, wedge-shaped defects) - · Extended fissure sealing in molars and premolars - · Veneering of discoloured anterior teeth - · Repair of composite and ceramic veneers
    Device Description
    R&D Series Nova Compo N is a light-curing, radiopaque, nano hybrid composite for anterior and posterior restorations. According to the applicable FDA recognized consensus standard: ISO 4049:2009 "Dentistry-Polymer Based Restorative Materials", this device is classified into the following: - -Type 1: polymer-based filling and restorative materials; -Class 2: Materials whose setting is effected by light; -Group 1: Materials whose use requires the energy to be applied intra-orally. R&D Series Nova Compo N light cure nano hybrid composite is designed with the high reduced shrinkage resin. The higher molecular weight of the resin results in less shrinkage, reduced aging and a slightly softer resin matrix. Additionally these resins impart a greater hydrophobicity and are less water absorption. Prepolymerized fillers provide low stress, non-sticky, easy handling and shaping formulation. High loading Prepolymerized fillers provide better wear resistance than traditional less loaded Prepolymerized fillers in other marketing composites. The nanofillers provide high polish, high wear, surface hardness and making the material smooth. R&D Series Nova Compo N light cure nano hybrid composite was tested for biocompability and found to be biocompatible as a result of testing.
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