510(k) · Cleared
ClearedLuxacore/Luxacore Dual
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmg USA, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Aug 23, 2001 as substantially equivalent to K932826 (Alpha-Dent, 1994) and 3 other predicates after a 31-day review. Its family tree reaches back 1 generation to 1987. 9 later devices descend from it.
- Decided
- Aug 23, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K872510 (1987). 4 ancestors in all. 9 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK872510 Den-Mat TenureDen-Mat Corp. · 1987
- This deviceK012307 Luxacore/Luxacore DualDmg USA, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK143104 Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG · 2015
- Descendant · cites it directly · 1 of its ownK092572 Core*IT DualSpident Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK262982 Core·it DualSpident Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK260805 Dual CoreVericom Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K143104Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG · 2015 · cites it directly1descendant
- K092572Core*IT DualSpident Co., Ltd. · 2009 · cites it directly1descendant
- K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · cites it directly1descendant
- K262982Core·it DualSpident Co., Ltd. · 2026 · 2 generations on0descendants
- K260805Dual CoreVericom Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872510 | Den-Mat Tenure | Den-Mat Corp. | 1987 | — |
| 0 (this device) | K012307 | Luxacore/Luxacore Dual | Dmg USA, Inc. | 2001 | — |
| +1 | K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Kettenbach GmbH & Co. KG | 2015 | — |
| +1 | K092572 | Core*IT Dual | Spident Co., Ltd. | 2009 | — |
| +1 | K041960 | Composite/Compomer Repair Kit | Dmg USA, Inc. | 2004 | — |
| +2 | K262982 | Core·it Dual | Spident Co., Ltd. | 2026 | — |
| +1 | K260805 | Dual Core | Vericom Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K932826 | Centrix's Encore Composite Resin Core Paste W\FluoSummary page 1…sification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: Centrix Encore (Alpha-Dent); K932826 Core Paste (Den-Mat); K872510 Bisfil 2B (BISCO); K964000 LuxaCore (Zenith); K982201 Product Description: LuxaCore: LuxaCore is… | 1994 |
| * | K872510 | Den-Mat TenureSummary page 1…on 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: Centrix Encore (Alpha-Dent); K932826 Core Paste (Den-Mat); K872510 Bisfil 2B (BISCO); K964000 LuxaCore (Zenith); K982201 Product Description: LuxaCore: LuxaCore is a chemical-curing, radiopaque… | 1987 |
| * | K964000 | Bisfil 2BSummary page 1…Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: Centrix Encore (Alpha-Dent); K932826 Core Paste (Den-Mat); K872510 Bisfil 2B (BISCO); K964000 LuxaCore (Zenith); K982201 Product Description: LuxaCore: LuxaCore is a chemical-curing, radiopaque two-component core build-up… | 1996 |
| * | K982201 | Zenith Luxacore Automix Core Material (Multiple)Summary page 1…e device classification is Class II. Predicate Devices: Centrix Encore (Alpha-Dent); K932826 Core Paste (Den-Mat); K872510 Bisfil 2B (BISCO); K964000 LuxaCore (Zenith); K982201 Product Description: LuxaCore: LuxaCore is a chemical-curing, radiopaque two-component core build-up material supplied in autom… | 1998 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 4 ancestors has a recall.
- Of its descendants, K143104 (Kettenbach GmbH & Co. KG, 2015) has gone furthest, with 1 descendant 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.
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?
The principal use for LuxaCore and LuxaCore Dual is as a core material either with adhesives or with pins or posts.
LuxaCore and LuxaCore Dual can also be used for:
Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
Repair material for provisionals
Bite registration material.
Build up material for plastic bite rails (occlusal individualisation).
Cement for pins and posts
Semipermanent restorative material (e.g., in childrens’ teeth)
LuxaCore can be used for luting of abutments to dentures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012307 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012307: Luxacore/Luxacore Dual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012307
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026