510(k) · Cleared

Cleared

AXCEL

K051931510(k) TraditionalCleared Feb 17, 2006219-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

Tri Dental Innovators · EBF Material, Tooth Shade, Resin

Cleared on Feb 17, 2006 as substantially equivalent to K920425 (3M Company, 1992) and 1 other predicate after a 219-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Feb 17, 2006
Review: 219 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K920425 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK920425 3M Brand Restorative Z1003M Company · 1992
This deviceK051931 AXCELTri Dental Innovators · 2006
Descendant · cites it directly · 0 of its ownK063714 Axcel FlowTri Dental Innovators · 2007

Most influential descendants

Showing 1 of 1 · See all

K063714Axcel FlowTri Dental Innovators · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920425	3M Brand Restorative Z100	3M Company	1992	—
0 (this device)	K051931	AXCEL	Tri Dental Innovators	2006	—
+1	K063714	Axcel Flow	Tri Dental Innovators	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K051931, 1992–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K920425	3M Brand Restorative Z100 Summary page 1 …Common Name: Dental Restorative Composite Classification Name: Tooth Shade Resin Material (per 21 CFR § 872.3690) Predicate Devices: 3)M Z IOO Restorative (K920425) Kerr Corporation Prodigy 4 (K990898) Device Description AXIOM is a light-cured hybrid dental restorat…	3M Company	1992	—
*	K990898	Prodigy 4 Summary page 1 …on Name: Tooth Shade Resin Material (per 21 CFR § 872.3690) Predicate Devices: 3)M Z IOO Restorative (K920425) Kerr Corporation Prodigy 4 (K990898) Device Description AXIOM is a light-cured hybrid dental restorative composite material, comprised of a Bis- GMA based resin, b…	Sybron Dental Specialties, Inc.	1999	—

Also cleared against K920425: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063714	Axcel Flow	Tri Dental Innovators	2007	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?

None of the 2 ancestors has a recall.
Of its descendants, K063714 (Tri Dental Innovators, 2007) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K920425.

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	—

What is it indicated for?

For direct restorations, for use in all classes of cavities, including veneers and incisal edge repairs.

For indirect anterior and posterior restorations, including inlays, onlays, and veneers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051931 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051931: AXCEL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051931

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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