(517 days)
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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I am sorry, but the provided text is a series of FDA 510(k) clearances for dental composite materials (Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Pag Flow). These documents primarily list the indications for use and confirm substantial equivalence to predicate devices. They do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies for an AI-based device.
Therefore, I cannot provide the requested information based on the given input. The categories you've asked about (e.g., test set, training set, experts, MRMC studies, standalone performance) are typically found in documentation for AI/software as a medical device (SaMD), not for physical dental materials like those described here.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.