510(k) · Cleared
ClearedCercon Base
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 Oct 25, 2001 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 281 later devices descend from it.
- Decided
- Oct 25, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
281 later devices descend from it, 15 citing it directly.
- This deviceK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
- Descendant · cites it directly · 251 of its ownK050903 Xawex G 100Wieland Dental + Technik GmbH & Co. KG · 2005
- Descendant · cites it directly · 191 of its ownK051462 Modification to: Cercon BaseDentsply Intl. · 2005
- Descendant · cites it directly · 186 of its ownK072569 Metoxit Cam-BlanksMetoxit AG · 2007
- Descendant · 2 generations on · 171 of its ownK061804 Zerion Alpha, ; Zerion BetaEtkon International GmbH · 2006
- Descendant · 3 generations on · 167 of its ownK080195 Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH · 2008
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 281 · See all- K050903Xawex G 100Wieland Dental + Technik GmbH & Co. KG · 2005 · cites it directly251descendants
- K051462Modification to: Cercon BaseDentsply Intl. · 2005 · cites it directly191descendants
- K072569Metoxit Cam-BlanksMetoxit AG · 2007 · cites it directly186descendants
- K061804Zerion Alpha, ; Zerion BetaEtkon International GmbH · 2006 · 2 generations on171descendants
- K080195Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH · 2008 · 3 generations on167descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013230 | Cercon Base | Degussa - Ney Dental, Inc. | 2001 | — |
| +1 | K050903 | Xawex G 100 | Wieland Dental + Technik GmbH & Co. KG | 2005 | — |
| +1 | K051462 | Modification to: Cercon Base | Dentsply Intl. | 2005 | — |
| +1 | K072569 | Metoxit Cam-Blanks | Metoxit AG | 2007 | — |
| +2 | K061804 | Zerion Alpha, ; Zerion Beta | Etkon International GmbH | 2006 | — |
| +3 | K080195 | Nacera Z and Nacera Z Medium | Doceram Medical Ceramics GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 9 | 0 |
| 2015 | 16 | 0 |
| 2016 | 10 | 0 |
| 2017 | 10 | 0 |
| 2018 | 15 | 0 |
| 2019 | 9 | 0 |
| 2020 | 18 | 0 |
| 2021 | 24 | 0 |
| 2022 | 22 | 0 |
| 2023 | 30 | 0 |
| 2024 | 34 | 0 |
| 2025 | 29 | 0 |
| 2026 | 15 | 0 |
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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (281)
See all 28115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050903 | Xawex G 100 | 2005 | 251 |
| K051462 | Modification to: Cercon Base | 2005 | 191 |
| K072569 | Metoxit Cam-Blanks | 2007 | 186 |
| K023327 | Cynovad Zirkon | 2002 | 91 |
| K043472 | Medin Tech Zirconia-CP10, SS1000 | 2005 | 80 |
| K062695 | Sagemax Z-Blank | 2006 | 76 |
| K112710 | Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR | 2011 | 16 |
| K041645 | DDS-ZR | 2004 | 8 |
| K112152 | Cercon HT | 2011 | 3 |
| K070045 | Zirblank-PS and Zirblank-FS | 2007 | 2 |
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, K050903 (Wieland Dental + Technik GmbH & Co. KG, 2005) has gone furthest, with 251 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 | — |
What is it indicated for?
Cercon Base is a patrtially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013230 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013230: Cercon Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013230
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026