510(k) · Cleared
ClearedCercon Ceram
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degussa - Ney Dental, Inc. · EIH Powder, Porcelain
Cleared on Aug 20, 2001 after a 110-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 20, 2001
- Review
- 110 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK011333 Cercon CeramDegussa - Ney Dental, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK022796 Cercon Ceram S PorcelainDentsply Intl. · 2002
- Descendant · cites it directly · 0 of its ownK063842 Cyrtina SystemOratio B.V. · 2007
- Descendant · 2 generations on · 0 of its ownK041707 Cercon Ceram Express Ceramic SystemDentsply Intl. · 2004
- Descendant · 2 generations on · 0 of its ownK033553 PFZ Porcelain SystemDentsply Intl. · 2003
Most influential descendants
Showing 4 of 4 · See all- K022796Cercon Ceram S PorcelainDentsply Intl. · 2002 · cites it directly2descendants
- K063842Cyrtina SystemOratio B.V. · 2007 · cites it directly0descendants
- K041707Cercon Ceram Express Ceramic SystemDentsply Intl. · 2004 · 2 generations on0descendants
- K033553PFZ Porcelain SystemDentsply Intl. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011333 | Cercon Ceram | Degussa - Ney Dental, Inc. | 2001 | — |
| +1 | K022796 | Cercon Ceram S Porcelain | Dentsply Intl. | 2002 | — |
| +1 | K063842 | Cyrtina System | Oratio B.V. | 2007 | — |
| +2 | K041707 | Cercon Ceram Express Ceramic System | Dentsply Intl. | 2004 | — |
| +2 | K033553 | PFZ Porcelain System | Dentsply Intl. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K022796 (Dentsply Intl., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 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/K011333 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011333: Cercon Ceram.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011333
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026