# K151399: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

- Pathway: 510(k) (Traditional)
- Applicant: Schutz Dental GmbH
- Decided: Oct 24, 2016 after 517 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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 |, Il, Ill, 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 | and Il cavities in areas not exposed to severe occlusal loads Minimally invasive fillings in Black's class IlI 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, llI, 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 |, Il and IlI 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 |, Il, Ill, 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 | and Il cavities in areas not exposed to severe occlusal loads Minimally invasive fillings in Black's class Il 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, I, lll, 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.

Source page: https://510kreport.com/device/K151399
Methodology: https://510kreport.com/methodology