510(k) · Cleared

Cleared

Kavo Everest ZH-Blank

K033221510(k) SpecialCleared Oct 28, 200325-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

Kavo America Corporation · EIH Powder, Porcelain

Cleared on Oct 28, 2003 as substantially equivalent to K032081 (Kavo America, 2003) and 2 other predicates after a 25-day review. Its family tree reaches back 2 generations to 2002.

Decided: Oct 28, 2003
Review: 25 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K022996 (2002). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
1 generation backK032081 Kavo Everest ZS-Blank Models, 42, 20, and 60Kavo America · 2003
This deviceK033221 Kavo Everest ZH-BlankKavo America Corporation · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K022996	Vita in-Ceram YZ Cubes for Cerec	Vident	2002	—
−1	K032081	Kavo Everest ZS-Blank Models, 42, 20, and 60	Kavo America	2003	—
0 (this device)	K033221	Kavo Everest ZH-Blank	Kavo America Corporation	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K033221, 2002–2003Source: 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 15.3 · 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? (3)

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
*	K032081	Kavo Everest ZS-Blank Models, 42, 20, and 60	Kavo America	2003	—
*	K030607	Kavo Everest G-Blank, Kavo Everest G-Ceram, Coating Ceramic LF-3-PFM, Glaze and…	Kavo America	2003	—
*	K022996	Vita in-Ceram YZ Cubes for Cerec Summary page 1 …t Code: EIH Panel: 76 Predicate devices: KO32081 KaVo Everest Z-Blank KaVo Everest G-Blank KO30607 and Vita inCeram Zirconia, K022996, among others. Device description: The KaVo Everest@ ZH-Blank is a pre-formed material for use by dental lab…	Vident	2002	—

Also cleared against K032081: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 9 months on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K032081.

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?

The KaVo Everest@ ZH-Blank is used in the manufacture of dental prosthetics.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033221 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033221: Kavo Everest ZH-Blank.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033221

Report an extraction error

Are you the manufacturer?

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