510(k) · Cleared

Cleared

Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B, and 6C

K011839510(k) TraditionalCleared Jan 17, 2002219-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

Doxa Certex AB · EBF Material, Tooth Shade, Resin

Cleared on Jan 17, 2002 after a 219-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jan 17, 2002
Review: 219 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK011839 Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B…Doxa Certex AB · 2002
Descendant · cites it directly · 1 of its ownK081405 XeracemDoxa Dental AB · 2008
Descendant · 2 generations on · 0 of its ownK100510 Ceramir Crown & BridgeDoxa AB · 2010

Most influential descendants

Showing 2 of 2 · See all

K081405XeracemDoxa Dental AB · 2008 · cites it directly1descendant
K100510Ceramir Crown & BridgeDoxa AB · 2010 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011839	Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B, and 6C	Doxa Certex AB	2002	—
+1	K081405	Xeracem	Doxa Dental AB	2008	—
+2	K100510	Ceramir Crown & Bridge	Doxa AB	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0

FIG. 1 — Lineage of K011839, 2002–2010Source: 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? (5)

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	Recalls
*	—	Dentsply AP Dyract® Compomer Named without a submission number	—
*	—	Bisco, Inc.’s PYRAMID™ dental composite Named without a submission number	—
*	—	Bisco, Inc.’s ADVENT™ dental composite Named without a submission number	—
*	—	Bisco, Inc.’s RENEW™ dental composite Named without a submission number	—
*	—	Colténe/Whaledent’s Coltosol Temporary Endodontic Filling Named without a submission number	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K081405	Xeracem	Doxa Dental AB	2008	1

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, K081405 (Doxa Dental AB, 2008) has gone furthest, with 1 descendant 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	—

What is it indicated for?

DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, I, and V cavities.

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/K011839 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011839: Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B, and 6C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011839

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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