510(k) · Cleared

Cleared

Zirblank-PS and Zirblank-FS

K070045510(k) TraditionalCleared Mar 26, 200781-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

Cleared on Mar 26, 2007 as substantially equivalent to K061804 (Etkon International GmbH, 2006) and 4 other predicates after an 81-day review. Its family tree reaches back 5 generations to 1983. 2 later devices descend from it.

Decided: Mar 26, 2007
Review: 81 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K830955 (1983). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
4 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
3 generations backK984201 DenzirDentronic AB · 1999
2 generations backK023327 Cynovad ZirkonCynovad · 2002
1 generation backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
This deviceK070045 Zirblank-PS and Zirblank-FSAcucera, Inc. · 2007
Descendant · cites it directly · 1 of its ownK081253 Zirdent Cad/Cam BlocksC5 Medical Werks, Inc. · 2008
Descendant · 2 generations on · 0 of its ownK091362 Ceramic Pedatric Preformed CrownEz-Pedo, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all

K081253Zirdent Cad/Cam BlocksC5 Medical Werks, Inc. · 2008 · cites it directly1descendant
K091362Ceramic Pedatric Preformed CrownEz-Pedo, Inc. · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K830955	Dental Ceramic for Fabrication of Crown	Dentsply Intl.	1983	—
−4	K971869	Finesse All-Ceramic System	Dentsply Intl.	1997	—
−3	K984201	Denzir	Dentronic AB	1999	—
−2	K023327	Cynovad Zirkon	Cynovad	2002	—
−1	K043472	Medin Tech Zirconia-CP10, SS1000	Medin Tech	2005	—
0 (this device)	K070045	Zirblank-PS and Zirblank-FS	Acucera, Inc.	2007	—
+1	K081253	Zirdent Cad/Cam Blocks	C5 Medical Werks, Inc.	2008	—
+2	K091362	Ceramic Pedatric Preformed Crown	Ez-Pedo, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1989	1	0
1992	1	0
1994	2	0
1998	1	0
2001	1	0
2005	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0

FIG. 1 — Lineage of K070045, 1983–2009Source: 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

Get a 510(k) Report

What was it cleared against? (7)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K061804	Zerion Alpha, ; Zerion Beta Summary page 1 …tive to devi':es currently on the market, cleared by the 510(k) process, ZirBlank-PS and ZirBlank-FS is substantially equivalent to Zerion Alpha; Zerion Beta, cleared in K061804, to Xavex cleared in K050;03, to Medin Tech Zirconia CPI 0, 1 00 01M cleared in K043472, and to Cynovad Zirkon cleared Lri K02332…	Etkon International GmbH	2006	—
Kept off the family tree	K050503	FDA’s K050503 is Single Use Aspiration Needle NA-201SX-4022 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Olympus Medical Systems Corporation	2005	5
*	K043472	Medin Tech Zirconia-CP10, SS1000 Summary page 1 …ZirBlank-FS is substantially equivalent to Zerion Alpha; Zerion Beta, cleared in K061804, to Xavex cleared in K050;03, to Medin Tech Zirconia CPI 0, 1 00 01M cleared in K043472, and to Cynovad Zirkon cleared Lri K023327 and equivalent to DenzirTM (Dentronic AB) cleared under K984201 as well as Crrcon Base…	Medin Tech	2005	—
*	K023327	Cynovad Zirkon Summary page 1 …Zerion Alpha; Zerion Beta, cleared in K061804, to Xavex cleared in K050;03, to Medin Tech Zirconia CPI 0, 1 00 01M cleared in K043472, and to Cynovad Zirkon cleared Lri K023327 and equivalent to DenzirTM (Dentronic AB) cleared under K984201 as well as Crrcon Base TM (Degussa Dental) cleared under K-013230…	Cynovad	2002	—
*	K984201	Denzir Summary page 1 …in K050;03, to Medin Tech Zirconia CPI 0, 1 00 01M cleared in K043472, and to Cynovad Zirkon cleared Lri K023327 and equivalent to DenzirTM (Dentronic AB) cleared under K984201 as well as Crrcon Base TM (Degussa Dental) cleared under K-013230. Like Zerion Alpha & Beta, it is intended Is be marketed both a…	Dentronic AB	1999	—
*	K013230	Cercon Base Summary page 1 …472, and to Cynovad Zirkon cleared Lri K023327 and equivalent to DenzirTM (Dentronic AB) cleared under K984201 as well as Crrcon Base TM (Degussa Dental) cleared under K-013230. Like Zerion Alpha & Beta, it is intended Is be marketed both as a partially sintered device which will then be machined and full…	Degussa - Ney Dental, Inc.	2001	—
*	—	Zerion Alpha Named without a submission number			—
†	K001815	DC Zirkon	Austenal, Inc.	2000	—
†	K950299	CEREC 2	Pelton & Crane Co.	1995	—
†	K972276	Cerec 2 Crown Software	Siemens AG	1997	—

Also cleared against K061804: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081253	Zirdent Cad/Cam Blocks	C5 Medical Werks, Inc.	2008	1

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 24 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K081253 (C5 Medical Werks, Inc., 2008) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K061804.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

Intended for' use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070045 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070045: Zirblank-PS and Zirblank-FS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070045

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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