510(k) · Cleared

Cleared

Artegral Imcrown

K061809510(k) TraditionalCleared Sep 13, 200678-day reviewClass II21 CFR 872.3770

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

Merz Dental GmbH · EBG Crown And Bridge, Temporary, Resin

Cleared on Sep 13, 2006 after a 78-day review. The FDA summary names its predicate without a number. 212 later devices descend from it.

Decided: Sep 13, 2006
Review: 78 days
Class: Class II
Product code: EBG
Recalls: None
Predicates: 0

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

This deviceK061809 Artegral ImcrownMerz Dental GmbH · 2006
Descendant · cites it directly · 211 of its ownK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017

Showing 5 of 212 descendants. See all descendants

Descendants cleared per year

2007high 31 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 212 · See all

K071548Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007 · cites it directly211descendants
K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K061809	Artegral Imcrown	Merz Dental GmbH	2006	—
+1	K071548	Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored	Merz Dental GmbH	2007	—
+2	K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…	Institut Straumann AG	2012	—
+3	K150203	Medentika CAD/CAM Abutments	Medentika GmbH	2015	—
+3	K150367	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
+4	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2012	1	0
2014	5	0
2015	9	0
2016	7	0
2017	7	0
2018	13	0
2019	11	0
2020	16	0
2021	21	0
2022	18	0
2023	31	0
2024	29	0
2025	25	0
2026	18	0

FIG. 1 — Lineage of K061809, 2006–2026Source: 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 EBG? 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 EBG device

#1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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? (1)

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
*	—	Temporary Crown and Bridge Resin Named without a submission number			—

What descends from it? (212)

See all 212

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

Number	Device	Applicant	Decided	Descendants
K071548	Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored	Merz Dental GmbH	2007	211
K140894	Argen Pmma	The Argen Corporation	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, K071548 (Merz Dental GmbH, 2007) has gone furthest, with 211 descendants of its own.

How does its category compare?

All EBG devices

EBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBG

4in 2025

2007high 14 (2020) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBG

106in 2025

2007high 265 (2021) · low 64 (2007)2026

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

Recalls per year · EBG

1in 2020

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · EBG

1in 2025

2007high 26 (2015) · low 0 (2018)2025

MAUDE reports naming product code EBG, 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	3	64	0	4
2008	9	83	0	4
2009	2	—	1	1
2010	5	103	0	1
2011	10	96	0	1
2012	5	90	0	5
2013	2	—	0	11
2014	3	114	0	23
2015	6	209	0	26
2016	4	163	0	8
2017	2	—	0	4
2018	4	202	0	0
2019	6	98	0	6
2020	14	194	1	2
2021	3	265	0	4
2022	3	73	0	2
2023	2	—	0	0
2024	5	144	0	0
2025	4	106	0	1
2026	2	—	0	—

What is it indicated for?

artegral inCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061809 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061809: Artegral Imcrown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061809

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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