510(k) · Cleared
ClearedCapo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schutz Dental GmbH · EBF Material, Tooth Shade, Resin
Cleared on Oct 24, 2016 after a 517-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 24, 2016
- Review
- 517 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
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…
Read the full statement (495 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151399: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151399
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026