510(k) · Cleared

Cleared

Xawex G 100

K050903510(k) TraditionalCleared Jun 23, 200573-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 Jun 23, 2005 as substantially equivalent to K013230 (Degussa - Ney Dental, Inc., 2001) after a 73-day review. Its family tree reaches back 1 generation to 2001. 251 later devices descend from it.

Decided: Jun 23, 2005
Review: 73 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K013230 (2001). 251 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
This deviceK050903 Xawex G 100Wieland Dental + Technik GmbH & Co. KG · 2005
Descendant · cites it directly · 186 of its ownK072569 Metoxit Cam-BlanksMetoxit AG · 2007
Descendant · cites it directly · 171 of its ownK061804 Zerion Alpha, ; Zerion BetaEtkon International GmbH · 2006
Descendant · 2 generations on · 167 of its ownK080195 Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH · 2008
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

Showing 5 of 251 descendants. See all descendants

Descendants cleared per year

2006high 32 (2024) · low 1 (2011)2026

Most influential descendants

Showing 5 of 251 · See all

K072569Metoxit Cam-BlanksMetoxit AG · 2007 · cites it directly186descendants
K061804Zerion Alpha, ; Zerion BetaEtkon International GmbH · 2006 · cites it directly171descendants
K080195Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH · 2008 · 2 generations on167descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013230	Cercon Base	Degussa - Ney Dental, Inc.	2001	—
0 (this device)	K050903	Xawex G 100	Wieland Dental + Technik GmbH & Co. KG	2005	—
+1	K072569	Metoxit Cam-Blanks	Metoxit AG	2007	—
+1	K061804	Zerion Alpha, ; Zerion Beta	Etkon International GmbH	2006	—
+2	K080195	Nacera Z and Nacera Z Medium	Doceram Medical Ceramics GmbH	2008	—
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	2	0
2008	6	0
2009	5	0
2010	4	0
2011	1	0
2012	3	0
2013	2	0
2014	7	0
2015	12	0
2016	8	0
2017	8	0
2018	14	0
2019	9	0
2020	17	0
2021	24	0
2022	22	0
2023	30	0
2024	32	0
2025	29	0
2026	14	0

FIG. 1 — Lineage of K050903, 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? (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
*	K013230	Cercon Base Summary page 1 …H C.D.R section: 872.6660 Classification: Class II Legally marketed equivalent device: Cercon Base 510(k) number: K013230 Premarket Notification 510 (k) 1 Xavex GO WIELAND Dental + Tec h n…	Degussa - Ney Dental, Inc.	2001	—

Also cleared against K013230: 14 other devices →

What descends from it? (251)

See all 251

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

Number	Device	Applicant	Decided	Descendants
K072569	Metoxit Cam-Blanks	Metoxit AG	2007	186
K061804	Zerion Alpha, ; Zerion Beta	Etkon International GmbH	2006	171
K062695	Sagemax Z-Blank	Sagemax Bioceramics, Inc.	2006	76
K081253	Zirdent Cad/Cam Blocks	C5 Medical Werks, Inc.	2008	1
K073568	PSL Biozir Block	P.S.L. International, Inc.	2008	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?

Its one ancestor has no recall.
Of its descendants, K072569 (Metoxit AG, 2007) has gone furthest, with 186 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.

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?

Xavex G100 is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations. It is a partially sintered yttria stabilized zirconium oxide powder that has to be machined with the CAD/CAM technique to its required shape and then sintered to full density.

Xavex G100 is recommended for manufacturing substructures of single tooth and bridgework with up to 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/K050903 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050903: Xawex G 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050903

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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