510(k) · Cleared
ClearedSR Nexco Paste Layering Materials, SR Nexco Opaquer, SR Nexco Liner-SR Nexco Connect, SR Nexco Stains, SR Nexco Retentio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · EBF Material, Tooth Shade, Resin
Cleared on Jan 24, 2013 after a 92-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jan 24, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK123304 SR Nexco Paste Layering Materials, SR Nexco Opaquer, SR Nexco…Ivoclar Vivadent, AG · 2013
- Descendant · cites it directly · 3 of its ownK152373 VITA VM LC FlowVita Zahnfabrik H.Rauter GmbH & Co. · 2015
- Descendant · 2 generations on · 1 of its ownK240660 Signum composite flow; Signum universal bond; Signum metal bond…Kulzer, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK251587 VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026
- Descendant · 2 generations on · 0 of its ownK230644 Signum opaque FKulzer, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K152373VITA VM LC FlowVita Zahnfabrik H.Rauter GmbH & Co. · 2015 · cites it directly3descendants
- K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…Kulzer, LLC · 2024 · 2 generations on1descendant
- K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg. · 2026 · 3 generations on0descendants
- K230644Signum opaque FKulzer, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123304 | SR Nexco Paste Layering Materials, SR Nexco Opaquer, SR Nexco Liner-SR Nexco… | Ivoclar Vivadent, AG | 2013 | — |
| +1 | K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015 | — |
| +2 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum… | Kulzer, LLC | 2024 | — |
| +3 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026 | — |
| +2 | K230644 | Signum opaque F | Kulzer, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152373 | VITA VM LC Flow | 2015 | 3 |
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.
What does this lineage say?
- Of its descendants, K152373 (Vita Zahnfabrik H.Rauter GmbH & Co., 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
SR Nexco is intended to be used as follows: Framework-based Veneering of metal-supported restorations Veneering of combination dentures (telescope crown veneers) Veneering of fixed-removable implant superstructures Veneering of gingiva portions in fixed removable implant superstructures Veneering of CAD/CAM fabricated metal frameworks Masking of model cast frameworks with SR Nexco Opaquer Pink Framework-Free Inlays/Onlays/veneers Anterior Crowns…
Read the full statement (124 words)
SR Nexco is intended to be used as follows:
Framework-based
Veneering of metal-supported restorations
Veneering of combination dentures (telescope crown veneers)
Veneering of fixed-removable implant superstructures
Veneering of gingiva portions in fixed removable implant superstructures
Veneering of CAD/CAM fabricated metal frameworks
Masking of model cast frameworks with SR Nexco Opaquer Pink
Framework-Free
Inlays/Onlays/veneers
Anterior Crowns
Modification/Characterization
Superficial characterization of Ivoclar Vivadent masin teeth with SR Nexco Stains in conjunction with SR Connect and subsequent layering with SR Nexco Paste layering materials
Shape and shade modifications of Ivoclar Vivadent resin teeth with SR Nexco Paste layering materials in conjunction with SR Connect
Modification and characterization of Telio CAD and Telio Lab with SR Nexco Stains, Dentin, Incisal and Effect Shades in conjunction with SR Connect
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123304: SR Nexco Paste Layering Materials, SR Nexco Opaquer, SR Nexco Liner-SR Nexco Connect, SR Nexco Stains, SR Nexco Retentio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123304
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026