510(k) · Cleared

Cleared

3M Espe Haur

K010781510(k) TraditionalCleared Apr 13, 200129-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

3M Company · EBF Material, Tooth Shade, Resin

Cleared on Apr 13, 2001 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 65 later devices descend from it.

Decided: Apr 13, 2001
Review: 29 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

65 later devices descend from it, 3 citing it directly.

This deviceK010781 3M Espe Haur3M Company · 2001
Descendant · cites it directly · 63 of its ownK020256 Unicem3M Espe AG Dental Products · 2002
Descendant · 2 generations on · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
Descendant · 2 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
Descendant · 3 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
Descendant · 2 generations on · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010

Showing 5 of 65 descendants. See all descendants

Descendants cleared per year

2002high 7 (2019) · low 0 (2006)2026

Most influential descendants

Showing 5 of 65 · See all

K020256Unicem3M Espe AG Dental Products · 2002 · cites it directly63descendants
K043043Hermes Bond 23M Espe AG Dental Products · 2005 · 2 generations on37descendants
K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
K100756MALTA3M Espe AG Dental Products · 2010 · 2 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010781	3M Espe Haur	3M Company	2001	—
+1	K020256	Unicem	3M Espe AG Dental Products	2002	—
+2	K043043	Hermes Bond 2	3M Espe AG Dental Products	2005	—
+2	K071131	UNO	3M Espe AG Dental Products	2007	—
+3	K110302	Adhesive Exl-759	3M Espe AG	2011	—
+2	K100756	MALTA	3M Espe AG Dental Products	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2007	2	0
2008	2	0
2010	2	0
2011	3	0
2012	2	0
2014	1	0
2015	3	0
2016	3	0
2017	2	0
2018	3	0
2019	7	0
2020	3	0
2021	2	0
2022	6	0
2023	3	0
2024	3	0
2025	6	0
2026	7	0

FIG. 1 — Lineage of K010781, 2001–2026Source: 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? (65)

See all 65

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

Number	Device	Applicant	Decided	Descendants
K020256	Unicem	3M Espe AG Dental Products	2002	63
K033996	Hermes	3M Espe AG Dental Products	2004	0
K033974	Hermes Bond	3M Espe AG Dental Products	2004	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, K020256 (3M Espe AG Dental Products, 2002) has gone furthest, with 63 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/K010781 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010781: 3M Espe Haur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010781

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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