510(k) · Cleared

Cleared

Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR

K112710510(k) SpecialCleared Oct 17, 201128-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

Wieland Dental + Technik GmbH & Co. KG · EIH Powder, Porcelain

Cleared on Oct 17, 2011 as substantially equivalent to K013230 (Degussa - Ney Dental, Inc., 2001) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it.

Decided: Oct 17, 2011
Review: 28 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K011394 (2001). 2 ancestors in all. 16 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK011394 Lava Frame, Lava Frame Shade, Lava CeramEspe Dental AG · 2001
This deviceK112710 Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR…Wieland Dental + Technik GmbH & Co. KG · 2011
Descendant · cites it directly · 4 of its ownK140070 Luxer Shaded ZirconiaContinental Dental Ceramics, Inc. · 2014
Descendant · cites it directly · 3 of its ownK133213 StarceramH.C. Starck Ceramics GmbH · 2013
Descendant · 2 generations on · 2 of its ownK172761 New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded &…Shanghai New Century Dental Materials Co., Ltd. · 2017
Descendant · cites it directly · 2 of its ownK120011 Heisenberg Effect Shades3M Espe AG · 2012
Descendant · 2 generations on · 1 of its ownK161922 XP2023M Deutschland GmbH · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2012high 4 (2015) · low 0 (2019)2026

Most influential descendants

Showing 5 of 16 · See all

K140070Luxer Shaded ZirconiaContinental Dental Ceramics, Inc. · 2014 · cites it directly4descendants
K133213StarceramH.C. Starck Ceramics GmbH · 2013 · cites it directly3descendants
K172761New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)Shanghai New Century Dental Materials Co., Ltd. · 2017 · 2 generations on2descendants
K120011Heisenberg Effect Shades3M Espe AG · 2012 · cites it directly2descendants
K161922XP2023M Deutschland GmbH · 2016 · 2 generations on1descendant

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)	K112710	Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR	Wieland Dental + Technik GmbH & Co. KG	2011	—
+1	K140070	Luxer Shaded Zirconia	Continental Dental Ceramics, Inc.	2014	—
+1	K133213	Starceram	H.C. Starck Ceramics GmbH	2013	—
+2	K172761	New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)	Shanghai New Century Dental Materials Co., Ltd.	2017	—
+1	K120011	Heisenberg Effect Shades	3M Espe AG	2012	—
+2	K161922	XP202	3M Deutschland GmbH	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	2	0
2014	2	0
2015	4	0
2016	1	0
2017	2	0
2018	1	0
2020	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K112710, 2001–2026Source: 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 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

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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
*	K013230	Cercon Base Summary page 1 …powder for clinical use Product code: EIH C.D.R section: 872.6660 Classification: Class 11 Legally marketed equivalent device: Cercon base (K013230) LAVA Frame; LAVA Frame Shade; LAVA Ceram (K01 1394) Page 9-1…	Degussa - Ney Dental, Inc.	2001	—
*	K011394	Lava Frame, Lava Frame Shade, Lava Ceram Summary page 1 …872.6660 Classification: Class 11 Legally marketed equivalent device: Cercon base (K013230) LAVA Frame; LAVA Frame Shade; LAVA Ceram (K01 1394) Page 9-1 510 (k) Summary Device description ZENO Zr Disc is a grou…	Espe Dental AG	2001	—

Also cleared against K013230: 14 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K140070	Luxer Shaded Zirconia	Continental Dental Ceramics, Inc.	2014	4
K133213	Starceram	H.C. Starck Ceramics GmbH	2013	3
K120011	Heisenberg Effect Shades	3M Espe AG	2012	2
K142233	zenostar MO, Zenostar T, Zenostar VisualiZr	Wieland Dental + Technik GmbH & Co. KG	2015	1
K140491	Tanaka Zircolor Coloring Liquid, Tanaka Zircolor Dipping Liquid and Tanaka Enamel ZR…	Tanaka Dental	2015	0
K130184	Zenolux	Wieland Dental + Technik GmbH & Co. KG	2013	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, K140070 (Continental Dental Ceramics, Inc., 2014) has gone furthest, with 4 descendants of its own.
14 other devices also cite its predicate K013230.

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?

ZENO Zr Disc is intended to be used by professional dental technicians for fabrication of all-ceramic restorations for the sole use of particular patients. It is recommended for manufacturing single-tooth and bridgework restorations, like crowns and bridges with one or two pontics, which can be used in the anterior as well as in the posterior tooth region.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112710 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112710

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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