510(k) · Cleared

Cleared

Flowable Composite/ Ecuflow/ Luxaflow

K011211510(k) TraditionalCleared Jun 18, 200160-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

Dmg USA, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Jun 18, 2001 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided: Jun 18, 2001
Review: 60 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

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

This deviceK011211 Flowable Composite/ Ecuflow/ LuxaflowDmg USA, Inc. · 2001
Descendant · cites it directly · 11 of its ownK013674 Luxatemp/Luxatemp Solar/InstatempDmg USA, Inc. · 2002
Descendant · 2 generations on · 7 of its ownK101710 Luxatemp Ultra /StarDmg USA, Inc. · 2010
Descendant · 2 generations on · 4 of its ownK073296 TEMPXN283M Espe AG Dental Products · 2008
Descendant · 3 generations on · 1 of its ownK200039 P pro Crown & BridgeDeltamed GmbH · 2020
Descendant · 3 generations on · 0 of its ownK251271 TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd. · 2025

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2002high 2 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 13 · See all

K013674Luxatemp/Luxatemp Solar/InstatempDmg USA, Inc. · 2002 · cites it directly11descendants
K101710Luxatemp Ultra /StarDmg USA, Inc. · 2010 · 2 generations on7descendants
K073296TEMPXN283M Espe AG Dental Products · 2008 · 2 generations on4descendants
K200039P pro Crown & BridgeDeltamed GmbH · 2020 · 3 generations on1descendant
K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd. · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011211	Flowable Composite/ Ecuflow/ Luxaflow	Dmg USA, Inc.	2001	—
+1	K013674	Luxatemp/Luxatemp Solar/Instatemp	Dmg USA, Inc.	2002	—
+2	K101710	Luxatemp Ultra /Star	Dmg USA, Inc.	2010	—
+2	K073296	TEMPXN28	3M Espe AG Dental Products	2008	—
+3	K200039	P pro Crown & Bridge	Deltamed GmbH	2020	—
+3	K251271	TempFIT Temporary Crown and Bridge Resin	Rizhao Huge Biomaterials Company, Ltd.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2008	1	0
2010	1	0
2012	1	0
2014	2	0
2015	1	0
2019	2	0
2020	1	0
2022	1	0
2025	2	0

FIG. 1 — Lineage of K011211, 2001–2025Source: 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? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K013674	Luxatemp/Luxatemp Solar/Instatemp	Dmg USA, Inc.	2002	11
K140570	Chairside Attachment Processing Material	Zest Anchors, 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, K013674 (Dmg USA, Inc., 2002) has gone furthest, with 11 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/K011211 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011211: Flowable Composite/ Ecuflow/ Luxaflow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011211

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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