510(k) · Cleared

Cleared

Cercon Ceram S Porcelain

K022796510(k) SpecialCleared Sep 6, 200214-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 Sep 6, 2002 as substantially equivalent to K011333 (Degussa - Ney Dental, Inc., 2001) after a 14-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.

Decided: Sep 6, 2002
Review: 14 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011333 (2001). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK011333 Cercon CeramDegussa - Ney Dental, Inc. · 2001
This deviceK022796 Cercon Ceram S PorcelainDentsply Intl. · 2002
Descendant · cites it directly · 0 of its ownK041707 Cercon Ceram Express Ceramic SystemDentsply Intl. · 2004
Descendant · cites it directly · 0 of its ownK033553 PFZ Porcelain SystemDentsply Intl. · 2003

Most influential descendants

Showing 2 of 2 · See all

K041707Cercon Ceram Express Ceramic SystemDentsply Intl. · 2004 · cites it directly0descendants
K033553PFZ Porcelain SystemDentsply Intl. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011333	Cercon Ceram	Degussa - Ney Dental, Inc.	2001	—
0 (this device)	K022796	Cercon Ceram S Porcelain	Dentsply Intl.	2002	—
+1	K041707	Cercon Ceram Express Ceramic System	Dentsply Intl.	2004	—
+1	K033553	PFZ Porcelain System	Dentsply Intl.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K022796, 2001–2004Source: 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
*	K011333	Cercon Ceram Summary page 1 …ations. Applications include both anterior and posterior locations. TECHNOLOGICAL CHARACTERISTICS: CERCONO CERAM S PORCELAIN represents a modification to Cercon@ Ceram 6011333). Minor changes have been made in the device's formulation. All of the components have been used in legally marketed devices. CE…	Degussa - Ney Dental, Inc.	2001	—

Also cleared against K011333: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K041707	Cercon Ceram Express Ceramic System	Dentsply Intl.	2004	0
K033553	PFZ Porcelain System	Dentsply Intl.	2003	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, K041707 (Dentsply Intl., 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011333.

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?

Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022796: Cercon Ceram S Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022796

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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