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510(k) Data Aggregation

    K Number
    K151399
    Device Name
    Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
    Manufacturer
    Date Cleared
    2016-10-24

    (517 days)

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

    SCHUTZ DENTAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Capo Hybrid is a light-curing hybrid composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. It can be polished to a high lustre. Applications are: Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities. Indirect restorations such as inlays, onlays and laminate veneers. Extended fissure sealing in molars and premolars. Endodontic posts. Splinting mobile teeth. Adjusting the contours and shades to improve aesthetics. Capo Flow is a light-curing, flowable, radiopaque, low viscosity composite. Applications are: Fissure sealing. Extensive fissure sealing on molars and premolars. Fillings in Black's class V cavities (cervical caries, eroded areas in roots, wedge-shaped defects). Minimally invasive fillings in Black's class I and II cavities in areas not exposed to severe occlusal loads. Minimally invasive fillings in Black's class III cavities. Restoring defects in enamel. Blocking out undercuts. Minimal adjustments to the contours and shade of the enamel. Capo Natural is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. Applications are: Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities. Indirect restorations such as inlays, onlays and laminate veneers. Extended fissure sealing in molars and premolars. Endodontic posts. Splinting mobile teeth. Adjusting the contours and shades to improve aesthetics. Capo Slow Flow is a light-curing, flowable, highly radiopaque (210 % Al) composite with a high viscosity. Applications are: Fissure sealing. Extensive fissure sealing on molars and premolars. Fillings in Black's class V (cervical caries, root erosions, v-shaped lesions). Minimally invasive fillings in Black's classes I, II and III. Corrections of enamel defects. Blocking out undercuts. Small corrections of shape and colour of the enamel. Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques. Applications are: Direct anterior and posterior restorations in Black's class I, II, III, IV, and V cavities. Indirect restorations such as inlays, onlays and laminate veneers. Extended fissure sealing in molars and premolars. Endodontic posts. Splinting mobile teeth. Adjusting the contours and shades to improve aesthetics. NanoPaq Flow is a light-curing, flowable, radiopaque, low viscosity composite. Applications are: Fissure sealing. Extensive fissure sealing on molars and premolars. Fillings in Black's class V cavities (cervical caries, eroded areas in roots, wedge-shaped defects). Minimally invasive fillings in Black's class I and II cavities in areas not exposed to severe occlusal loads. Minimally invasive fillings in Black's class III cavities. Restoring defects in enamel. Blocking out undercuts. Minimal adjustments to the contours and shade of the enamel. NanoPaq is a light-curing nano-composite for the adhesive filling technique. It contains an ultrafine, radiopaque glass filler. Applications are: Direct anterior and posterior tooth restorations in Black's classes I, II, III, IV, and V. Indirect restorations such as inlays, onlays and veneers. Extended fissure sealing on molars and premolars. Building up stumps. Splinting of loosened teeth. Corrections of shape and colour to enhance aesthetics.
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