510(k) · Cleared
ClearedCeraroot Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oral Iceberg S.L. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 4, 2011 as substantially equivalent to K061971 (Nobel Biocare AB, 2007) and 1 other predicate after a 411-day review. Its family tree reaches back 2 generations to 2002. 27 later devices descend from it.
- Decided
- Jan 4, 2011
- Review
- 411 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022562 (2002). 4 ancestors in all. 27 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
- 1 generation backK061971 Zirconia ImplantNobel Biocare AB · 2007
- This deviceK093595 Ceraroot Implant SystemOral Iceberg S.L. · 2011
- Descendant · cites it directly · 19 of its ownK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
- Descendant · 2 generations on · 12 of its ownK151328 PURE Ceramic ImplantsStraumann USA · 2016
- Descendant · 3 generations on · 8 of its ownK171769 Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
- Descendant · 2 generations on · 8 of its ownK132881 Z5CZ-Systems AG · 2014
- Descendant · 4 generations on · 6 of its ownK180477 Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K120793Z-LOOK3 Evo SLMZ-Systems AG · 2012 · cites it directly19descendants
- K151328PURE Ceramic ImplantsStraumann USA · 2016 · 2 generations on12descendants
- K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017 · 3 generations on8descendants
- K132881Z5CZ-Systems AG · 2014 · 2 generations on8descendants
- K180477Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| −1 | K061971 | Zirconia Implant | Nobel Biocare AB | 2007 | — |
| 0 (this device) | K093595 | Ceraroot Implant System | Oral Iceberg S.L. | 2011 | — |
| +1 | K120793 | Z-LOOK3 Evo SLM | Z-Systems AG | 2012 | — |
| +2 | K151328 | PURE Ceramic Implants | Straumann USA | 2016 | — |
| +3 | K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017 | — |
| +2 | K132881 | Z5C | Z-Systems AG | 2014 | — |
| +4 | K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061971 | Zirconia ImplantSummary page 2…osseous, Root-Form Product Code(s) DZE Classification Panel Dental Devices Regulatory Class Class 11 Predicate Device(s) 1. Nobel Biocare AB - Zirconia Implant - (K061971) 2. Z-Systems AG - Z-Look3 Dental Implant System - (K062542) intended Use CeraRoot dental implants are especially designed for t… | 2007 |
| * | K062542 | Z-LOOK3 Dental Implant System, Model Z3-XXXSummary page 2…el Dental Devices Regulatory Class Class 11 Predicate Device(s) 1. Nobel Biocare AB - Zirconia Implant - (K061971) 2. Z-Systems AG - Z-Look3 Dental Implant System - (K062542) intended Use CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the… | 2007 |
What descends from it? (27)
See all 275 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 9 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120793 (Z-Systems AG, 2012) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K061971.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
CeraRoot dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot implants can be placed in immediate or delayed tooth extractions. CeraRoot implants are not intended for immediate loading. The CeraRoot dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093595: Ceraroot Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093595
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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