510(k) · Cleared

Cleared

Cyrtina System

K063842510(k) TraditionalCleared Apr 17, 2007112-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

Oratio B.V. · EIH Powder, Porcelain

Cleared on Apr 17, 2007 as substantially equivalent to K011394 (Espe Dental AG, 2001) and 7 other predicates after a 112-day review. Its family tree reaches back 3 generations to 1983.

Decided: Apr 17, 2007
Review: 112 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 8

Its longest line of descent runs back 3 generations to K830955 (1983). 15 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
2 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
1 generation backK984201 DenzirDentronic AB · 1999
This deviceK063842 Cyrtina SystemOratio B.V. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K830955	Dental Ceramic for Fabrication of Crown	Dentsply Intl.	1983	—
−2	K971869	Finesse All-Ceramic System	Dentsply Intl.	1997	—
−1	K984201	Denzir	Dentronic AB	1999	—
0 (this device)	K063842	Cyrtina System	Oratio B.V.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1990	1	0
1994	2	0
1998	3	0
2000	2	0
2001	2	0
2005	1	0

FIG. 1 — Lineage of K063842, 1983–2007Source: 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? (8)

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
*	K011394	Lava Frame, Lava Frame Shade, Lava Ceram Summary page 1 …aterial All ceramic overlay material Predicate Devices LAVA Frame K 011394 (3M ESPE) Denzir K 984201 (Dentronic) DCZirkon…	Espe Dental AG	2001	—
*	K984201	Denzir Summary page 1 …overlay material Predicate Devices LAVA Frame K 011394 (3M ESPE) Denzir K 984201 (Dentronic) DCZirkon K 001815 (Austenal) Willi Geller Creation Porcelai…	Dentronic AB	1999	—
*	K001815	DC Zirkon Summary page 1 …K 011394 (3M ESPE) Denzir K 984201 (Dentronic) DCZirkon K 001815 (Austenal) Willi Geller Creation Porcelain K 981490 (Jensen Industries) OPC 3G All-ceramic sys…	Austenal, Inc.	2000	—
*	K981490	Willi Geller Creation Porcelain Summary page 1 …K 984201 (Dentronic) DCZirkon K 001815 (Austenal) Willi Geller Creation Porcelain K 981490 (Jensen Industries) OPC 3G All-ceramic system K 994435 (Jeneric Pentron) IPS Empress 2…	Jensen Industries, Inc.	1998	—
*	K994435	Opc 3G All-Ceramic System, Core and Overlay Porcelains Summary page 1 …K 001815 (Austenal) Willi Geller Creation Porcelain K 981490 (Jensen Industries) OPC 3G All-ceramic system K 994435 (Jeneric Pentron) IPS Empress 2 K 982616 (Ivoclar) Cercon Ceram Porcelain…	Jeneric/Pentron, Inc.	2000	—
*	K982616	Ips Empress 2 Summary page 1 …K 981490 (Jensen Industries) OPC 3G All-ceramic system K 994435 (Jeneric Pentron) IPS Empress 2 K 982616 (Ivoclar) Cercon Ceram Porcelain K 011333 (Dentsply) KATANA Zirconia…	Ivoclar North America, Inc.	1998	—
*	K011333	Cercon Ceram Summary page 1 …K 994435 (Jeneric Pentron) IPS Empress 2 K 982616 (Ivoclar) Cercon Ceram Porcelain K 011333 (Dentsply) KATANA Zirconia K 050160 (Noritake Company) 510(k) Cyrtina® System…	Degussa - Ney Dental, Inc.	2001	—
*	K050160	Katana Zirconia Summary page 1 …K 982616 (Ivoclar) Cercon Ceram Porcelain K 011333 (Dentsply) KATANA Zirconia K 050160 (Noritake Company) 510(k) Cyrtina® System Premarket Notification v. 1.2 14 -43…	Noritake Co., Inc.	2005	—

Also cleared against K011394: 14 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 24 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
None of the 15 ancestors has a recall.
14 other devices also cite its predicate K011394.

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?

The Cyrtina system is intended for CAD/CAM fabrication of allceramic dental restorations.

The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063842: Cyrtina System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063842

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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