510(k) · Cleared

Cleared

Heisenberg Dyeing Liquids

K111257510(k) TraditionalCleared May 13, 20119-day reviewClass II21 CFR 872.6660

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

3M Espe AG · EIH Powder, Porcelain

Cleared on May 13, 2011 as substantially equivalent to K011394 (Espe Dental AG, 2001) after a 9-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it.

Decided: May 13, 2011
Review: 9 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011394 (2001). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011394 Lava Frame, Lava Frame Shade, Lava CeramEspe Dental AG · 2001
This deviceK111257 Heisenberg Dyeing Liquids3M Espe AG · 2011
Descendant · cites it directly · 5 of its ownK182833 ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier…The Argen Corporation · 2019
Descendant · 2 generations on · 3 of its ownK190518 Color Liquid, Vita LiquidZirkonzahn Srl · 2019
Descendant · 3 generations on · 1 of its ownK220960 BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc. · 2022
Descendant · 4 generations on · 0 of its ownK231347 BruxZir™ TintEFX Coloring LiquidPrismatik Dentalcraft, Inc. · 2023
Descendant · 2 generations on · 0 of its ownK230262 BruxZir™ Incisal Coloring LiquidPrismatik Dentalcraft, Inc. · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019high 2 (2019) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all

K182833ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic ReducerThe Argen Corporation · 2019 · cites it directly5descendants
K190518Color Liquid, Vita LiquidZirkonzahn Srl · 2019 · 2 generations on3descendants
K220960BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc. · 2022 · 3 generations on1descendant
K231347BruxZir™ TintEFX Coloring LiquidPrismatik Dentalcraft, Inc. · 2023 · 4 generations on0descendants
K230262BruxZir™ Incisal Coloring LiquidPrismatik Dentalcraft, Inc. · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011394	Lava Frame, Lava Frame Shade, Lava Ceram	Espe Dental AG	2001	—
0 (this device)	K111257	Heisenberg Dyeing Liquids	3M Espe AG	2011	—
+1	K182833	ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ…	The Argen Corporation	2019	—
+2	K190518	Color Liquid, Vita Liquid	Zirkonzahn Srl	2019	—
+3	K220960	BruxZir Opaque Coloring Liquid	Prismatik Dentalcraft, Inc.	2022	—
+4	K231347	BruxZir™ TintEFX Coloring Liquid	Prismatik Dentalcraft, Inc.	2023	—
+2	K230262	BruxZir™ Incisal Coloring Liquid	Prismatik Dentalcraft, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0
2022	2	0
2023	2	0

FIG. 1 — Lineage of K111257, 2001–2023Source: 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 EIH? 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 EIH device

#1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K011394	Lava Frame, Lava Frame Shade, Lava Ceram Summary page 1 …der for clinical use Common Name: ........................................ Dyeing liquid Predicate Device Lava Frame Shade by 3M ESPE, Germany..........(011394 Description for thle Premarket Notification H-eisenberg Dyeing Liquid is classified as Porcelain powder for Clin…	Espe Dental AG	2001	—

Also cleared against K011394: 14 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K182833	ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer	The Argen Corporation	2019	5

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?

Its one ancestor has no recall.
Of its descendants, K182833 (The Argen Corporation, 2019) has gone furthest, with 5 descendants of its own.
14 other devices also cite its predicate K011394.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · EIH

13in 2025

2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007high 187 (2016) · low 63 (2007)2026

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

Recalls per year · EIH

1in 2025

2007high 21 (2016) · low 0 (2007)2026

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

Adverse event reports per year · EIH

1in 2025

2007high 22 (2021) · low 0 (2007)2025

MAUDE reports naming product code EIH, 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	15	63	0	0
2008	15	87	0	1
2009	15	79	0	0
2010	14	89	0	0
2011	14	80	0	1
2012	9	96	0	0
2013	16	107	0	6
2014	18	118	0	1
2015	23	118	0	0
2016	22	187	21	4
2017	16	149	0	1
2018	10	139	0	2
2019	16	125	0	1
2020	13	155	0	0
2021	17	131	0	22
2022	16	89	0	0
2023	15	114	0	0
2024	28	89	0	7
2025	13	84	1	1
2026	14	73	0	—

What is it indicated for?

Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111257 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111257: Heisenberg Dyeing Liquids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111257

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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