510(k) · Cleared
ClearedVisalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kettenbach GmbH & Co. KG · EBF Material, Tooth Shade, Resin
Cleared on Mar 25, 2015 as substantially equivalent to K012307 (Dmg USA, Inc., 2001) and 2 other predicates after a 147-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Mar 25, 2015
- Review
- 147 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K872510 (1987). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK872510 Den-Mat TenureDen-Mat Corp. · 1987
- 1 generation backK012307 Luxacore/Luxacore DualDmg USA, Inc. · 2001
- This deviceK143104 Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG · 2015
- Descendant · cites it directly · 0 of its ownK191527 Visalys CemCore, Visalys Cem Core Try In PasteKettenbach GmbH & Co. KG · 2019
Most influential descendants
Showing 1 of 1 · See all- K191527Visalys CemCore, Visalys Cem Core Try In PasteKettenbach GmbH & Co. KG · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872510 | Den-Mat Tenure | Den-Mat Corp. | 1987 | — |
| −1 | K012307 | Luxacore/Luxacore Dual | Dmg USA, Inc. | 2001 | — |
| 0 (this device) | K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Kettenbach GmbH & Co. KG | 2015 | — |
| +1 | K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012307 | Luxacore/Luxacore DualSummary page 5…ry Status: Class II C. Predicate devices: Device Trade Name: LuxaCore Dual Applicant: DMG USA, Inc. 510(k) No.: K012307 Device Trade Name: MULTICORE FLOW Applicant: Ivoclar Vivadent, Inc. 510(k) No.: K040795… | 2001 |
| * | K040795 | Multicore HB; Multicore FlowSummary page 5…DMG USA, Inc. 510(k) No.: K012307 Device Trade Name: MULTICORE FLOW Applicant: Ivoclar Vivadent, Inc. 510(k) No.: K040795 Device Trade Name: Rebilda DC Applicant: Voco, GmbH 510(k) No.: K040795… | 2004 |
| * | K060893 | Modification to Rebilda DCSummary page 9…ys® Core / PL-Core-Variants dual-curing core built-up materials are considered substantially equivalent to LuxaCore Dual (K012307), MULTICORE FLOW (K040795), Rebilda DC (K060893). There is no significant difference in intended use or technology. Each version of the Visalys Core material is substantially eq… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | 2019 | 0 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K191527 (Kettenbach GmbH & Co. KG, 2019) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K012307.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Visalys® Core, PL-Core, PL-Core-C, PL-Core-X are dual-curing core build-up materials which are intended to be used for different types of core build-ups and luting of root posts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143104 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143104: Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143104
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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