510(k) · Cleared
ClearedNacera Z and Nacera Z Medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doceram Medical Ceramics GmbH · EIH Powder, Porcelain
Cleared on Apr 28, 2008 as substantially equivalent to K061804 (Etkon International GmbH, 2006) after a 94-day review. Its family tree reaches back 3 generations to 2001. 167 later devices descend from it.
- Decided
- Apr 28, 2008
- Review
- 94 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013230 (2001). 167 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
- 2 generations backK050903 Xawex G 100Wieland Dental + Technik GmbH & Co. KG · 2005
- 1 generation backK061804 Zerion Alpha, ; Zerion BetaEtkon International GmbH · 2006
- This deviceK080195 Nacera Z and Nacera Z MediumDoceram Medical Ceramics GmbH · 2008
- Descendant · cites it directly · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 2 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Showing 5 of 167 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 167 · See all- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · cites it directly165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 2 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 4 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013230 | Cercon Base | Degussa - Ney Dental, Inc. | 2001 | — |
| −2 | K050903 | Xawex G 100 | Wieland Dental + Technik GmbH & Co. KG | 2005 | — |
| −1 | K061804 | Zerion Alpha, ; Zerion Beta | Etkon International GmbH | 2006 | — |
| 0 (this device) | K080195 | Nacera Z and Nacera Z Medium | Doceram Medical Ceramics GmbH | 2008 | — |
| +1 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +2 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +4 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K061804 | Zerion Alpha, ; Zerion BetaSummary page 1…ion 872.6660 Classification Class II Legally marketed equvalent device Zerion beta 510 (k) number K061804 Device Description Nacera Z is a ceramic material for dental restorations.… | 2006 |
What descends from it? (167)
See all 1672 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 7 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120822 (Institut Straumann AG, 2012) has gone furthest, with 165 descendants of its own.
- 2 other devices also cite its predicate K061804.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Nacera Z and Nacera Z Medium are a dental ceramic designed to be used by dental technicians to manufacture all-ceramic restorations. Nacera Z and Nacera Z medium are Yttria (Yttrium Oxide) stabilized tetragonal zirconia (Zirconia oxide) powder delivered in a partially sintered state.
Nacera Z and Nacera Z Medium is specially designed for use as framework (substructure) for dental restorations, single tooth or bridge type application at anterior and posterior locations.
It is prepared for machining by use of CAM-techniques.
The machined frameworks like dental crown and bridge works are sintered to full density.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080195: Nacera Z and Nacera Z Medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080195
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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