510(k) · Cleared

Cleared

Cerec Vitablocks MK2

K022408510(k) TraditionalCleared Sep 6, 200244-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

B.B.'S Prophy Shop · EIH Powder, Porcelain

Cleared on Sep 6, 2002 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it.

Decided: Sep 6, 2002
Review: 44 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 0

21 later devices descend from it, 3 citing it directly.

This deviceK022408 Cerec Vitablocks MK2B.B.'S Prophy Shop · 2002
Descendant · cites it directly · 19 of its ownK053438 Glass Ceramics3M Espe AG Dental Products · 2006
Descendant · 2 generations on · 12 of its ownK063511 Ceramill ZIAmann Girrbach America, Inc. · 2007
Descendant · 3 generations on · 5 of its ownK092513 Rainbow BlockGenoss Co., Ltd. · 2009
Descendant · 3 generations on · 3 of its ownK152383 Ceramill Zolid FXEmergo Europe Consulting · 2015
Descendant · 4 generations on · 2 of its ownK151842 Rainbow ShineGenoss · 2016

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2006high 3 (2009) · low 0 (2008)2026

Most influential descendants

Showing 5 of 21 · See all

K053438Glass Ceramics3M Espe AG Dental Products · 2006 · cites it directly19descendants
K063511Ceramill ZIAmann Girrbach America, Inc. · 2007 · 2 generations on12descendants
K092513Rainbow BlockGenoss Co., Ltd. · 2009 · 3 generations on5descendants
K152383Ceramill Zolid FXEmergo Europe Consulting · 2015 · 3 generations on3descendants
K151842Rainbow ShineGenoss · 2016 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022408	Cerec Vitablocks MK2	B.B.'S Prophy Shop	2002	—
+1	K053438	Glass Ceramics	3M Espe AG Dental Products	2006	—
+2	K063511	Ceramill ZI	Amann Girrbach America, Inc.	2007	—
+3	K092513	Rainbow Block	Genoss Co., Ltd.	2009	—
+3	K152383	Ceramill Zolid FX	Emergo Europe Consulting	2015	—
+4	K151842	Rainbow Shine	Genoss	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2009	3	0
2010	1	0
2011	1	0
2013	1	0
2015	3	0
2016	3	0
2017	1	0
2018	2	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K022408, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K053438	Glass Ceramics	3M Espe AG Dental Products	2006	19
K152274	MSCB-001	GC America, Inc.	2016	0
K111573	Monobloc BM Series	Hass Corp.	2011	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?

Of its descendants, K053438 (3M Espe AG Dental Products, 2006) has gone furthest, with 19 descendants of its own.

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	—

https://510kreport.com/device/K022408 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022408: Cerec Vitablocks MK2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022408

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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