510(k) · Cleared

Cleared

Den-Mat Tenure

K872510510(k) TraditionalCleared Aug 24, 198761-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Den-Mat Corp. · EBF Material, Tooth Shade, Resin

Cleared on Aug 24, 1987 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided: Aug 24, 1987
Review: 61 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

11 later devices descend from it, 2 citing it directly.

This deviceK872510 Den-Mat TenureDen-Mat Corp. · 1987
Descendant · cites it directly · 9 of its ownK012307 Luxacore/Luxacore DualDmg USA, Inc. · 2001
Descendant · 2 generations on · 1 of its ownK143104 Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG · 2015
Descendant · 2 generations on · 1 of its ownK092572 Core*IT DualSpident Co., Ltd. · 2009
Descendant · 2 generations on · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
Descendant · 3 generations on · 0 of its ownK262982 Core·it DualSpident Co., Ltd. · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2001high 2 (2026) · low 0 (2002)2026

Most influential descendants

Showing 5 of 11 · See all

K012307Luxacore/Luxacore DualDmg USA, Inc. · 2001 · cites it directly9descendants
K143104Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XKettenbach GmbH & Co. KG · 2015 · 2 generations on1descendant
K092572Core*IT DualSpident Co., Ltd. · 2009 · 2 generations on1descendant
K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · 2 generations on1descendant
K262982Core·it DualSpident Co., Ltd. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K872510	Den-Mat Tenure	Den-Mat Corp.	1987	—
+1	K012307	Luxacore/Luxacore Dual	Dmg USA, Inc.	2001	—
+2	K143104	Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X	Kettenbach GmbH & Co. KG	2015	—
+2	K092572	Core*IT Dual	Spident Co., Ltd.	2009	—
+2	K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	—
+3	K262982	Core·it Dual	Spident Co., Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0
2007	1	0
2009	1	0
2013	1	0
2014	1	0
2015	1	0
2019	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K872510, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012307	Luxacore/Luxacore Dual	Dmg USA, Inc.	2001	9
K140537	TENURE4G	Den-Mat Holdings, LLC	2014	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?

Of its descendants, K012307 (Dmg USA, Inc., 2001) has gone furthest, with 9 descendants of its own.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)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	—

https://510kreport.com/device/K872510 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872510: Den-Mat Tenure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872510

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026