510(k) · Cleared
ClearedZerion Alpha, ; Zerion Beta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etkon International GmbH · EIH Powder, Porcelain
Cleared on Oct 6, 2006 as substantially equivalent to K050903 (Wieland Dental + Technik GmbH & Co. KG, 2005) after a 101-day review. Its family tree reaches back 2 generations to 2001. 171 later devices descend from it.
- Decided
- Oct 6, 2006
- Review
- 101 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013230 (2001). 171 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
- 1 generation backK050903 Xawex G 100Wieland Dental + Technik GmbH & Co. KG · 2005
- This deviceK061804 Zerion Alpha, ; Zerion BetaEtkon International GmbH · 2006
- Descendant · cites it directly · 167 of its ownK080195 Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH · 2008
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · See all- K080195Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH · 2008 · cites it directly167descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013230 | Cercon Base | Degussa - Ney Dental, Inc. | 2001 | — |
| −1 | K050903 | Xawex G 100 | Wieland Dental + Technik GmbH & Co. KG | 2005 | — |
| 0 (this device) | K061804 | Zerion Alpha, ; Zerion Beta | Etkon International GmbH | 2006 | — |
| +1 | K080195 | Nacera Z and Nacera Z Medium | Doceram Medical Ceramics GmbH | 2008 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +3 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 17 | 0 |
| 2022 | 14 | 0 |
| 2023 | 24 | 0 |
| 2024 | 24 | 0 |
| 2025 | 25 | 0 |
| 2026 | 11 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K050903 | Xawex G 100Summary page 1…ction 872.6660 Classification Class II Legally marketed equvalent device XAWEX G 00 510 (k) number K050903 Device Description Z E R I O N is a dental ceramic being composed of partially… | 2005 |
What descends from it? (171)
See all 1713 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080195 (Doceram Medical Ceramics GmbH, 2008) has gone furthest, with 167 descendants of its own.
- 4 other devices also cite its predicate K050903.
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?
ZERION is a dental ceramic designed for the labrication of dental restorations by dental technicians.
ZERION delivery state is a yttria (yttrium oxide) - stabilized tetragonal zirconia (zirconium oxide) powder, already partially sintered and made for machining by use of CAD/CAM-techniques. The machined frameworks (dental crown and bridge works) are then sintered to full density.
ZERION is especially designed for use as framework (substructure) for dental restorations including single tooth or bridge type applications on both anterior and posterior locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061804 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061804: Zerion Alpha, ; Zerion Beta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061804
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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