510(k) · Cleared

Cleared

VITA YZ ST and VITA YZ XT

K180703510(k) AbbreviatedCleared Aug 1, 2018135-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

Vita Zahnfabrik H.Rauter GmbH Co. · EIH Powder, Porcelain

Cleared on Aug 1, 2018 as substantially equivalent to K022996 (Vident, 2002) after a 135-day review. Its family tree reaches back 1 generation to 2002. 9 later devices descend from it.

Decided: Aug 1, 2018
Review: 135 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K022996 (2002). 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
This deviceK180703 VITA YZ ST and VITA YZ XTVita Zahnfabrik H.Rauter GmbH Co. · 2018
Descendant · cites it directly · 7 of its ownK183304 Prettau, ICE, Z-White zirconia blanksZirkonzahn Srl · 2019
Descendant · 2 generations on · 3 of its ownK222626 Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2022
Descendant · 2 generations on · 1 of its ownK212765 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2021
Descendant · 3 generations on · 0 of its ownK260370 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026
Descendant · 3 generations on · 0 of its ownK250811 Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2019high 2 (2022) · low 0 (2020)2026

Most influential descendants

Showing 5 of 9 · See all

K183304Prettau, ICE, Z-White zirconia blanksZirkonzahn Srl · 2019 · cites it directly7descendants
K222626Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2022 · 2 generations on3descendants
K212765Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2021 · 2 generations on1descendant
K260370Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026 · 3 generations on0descendants
K250811Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd. · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022996	Vita in-Ceram YZ Cubes for Cerec	Vident	2002	—
0 (this device)	K180703	VITA YZ ST and VITA YZ XT	Vita Zahnfabrik H.Rauter GmbH Co.	2018	—
+1	K183304	Prettau, ICE, Z-White zirconia blanks	Zirkonzahn Srl	2019	—
+2	K222626	Dental Zirconia Ceramic	Aidite (Qinhuangdao) Technology Co., Ltd.	2022	—
+2	K212765	Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	Bloomden Bioceramics (HuNan) Co., Ltd.	2021	—
+3	K260370	Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	Bloomden Bioceramics (HuNan) Co., Ltd.	2026	—
+3	K250811	Dental Zirconia Ceramic	Aidite (Qinhuangdao) Technology Co., Ltd.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2021	1	0
2022	2	0
2024	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K180703, 2002–2026Source: 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
*	K022996	Vita in-Ceram YZ Cubes for Cerec Summary page 4 … Regulation Number 21 CFR 872.6660  Product Code EIH Predicate Devices VITA In–CERAM YZ Cubes for CEREC® (VITA Zahnfabrik GmbH) – K022996 – Primary Predicate VITA YZ® ST and VITA YZ® XT - 510(k) Premarket Notification Page 1 === Page 5 =…	Vident	2002	—
†	K161025	priti multidisc ZrO2 High Translucent	Pritidenta GmbH	2017	—

Also cleared against K022996: 8 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K183304	Prettau, ICE, Z-White zirconia blanks	Zirkonzahn Srl	2019	7
K243940	VITA YZ Multi Translucent	Vita Zahnfabrik H.Rauter GmbH & Co.	2025	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, K183304 (Zirkonzahn Srl, 2019) has gone furthest, with 7 descendants of its own.
8 other devices also cite its predicate K022996.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?

VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.

VITA YZ® ST is indicated for fully anatomical anterior and posterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.

VITA YZ® XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.

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/K180703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180703: VITA YZ ST and VITA YZ XT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180703

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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