510(k) · Cleared
ClearedStraumann® PURE Ceramic Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · DZE Implant, Endosseous, Root-Form
Cleared on Dec 10, 2024 as substantially equivalent to K171769 (Straumann USA, LLC (On Behalf of Institut Straumann Ag), 2017) after a 209-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Dec 10, 2024
- Review
- 209 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K022562 (2002). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
- 5 generations backK061971 Zirconia ImplantNobel Biocare AB · 2007
- 4 generations backK093595 Ceraroot Implant SystemOral Iceberg S.L. · 2011
- 3 generations backK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
- 2 generations backK151328 PURE Ceramic ImplantsStraumann USA · 2016
- 1 generation backK171769 Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
- This deviceK241391 Straumann® PURE Ceramic ImplantsInstitut Straumann AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| −5 | K061971 | Zirconia Implant | Nobel Biocare AB | 2007 | — |
| −4 | K093595 | Ceraroot Implant System | Oral Iceberg S.L. | 2011 | — |
| −3 | K120793 | Z-LOOK3 Evo SLM | Z-Systems AG | 2012 | — |
| −2 | K151328 | PURE Ceramic Implants | Straumann USA | 2016 | — |
| −1 | K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017 | — |
| 0 (this device) | K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K171769 | Straumann PURE Ceramic ImplantsSummary page 6…sion Straumann® PURE Ceramic Implants K241391 510(k) Summary Predicate Device(s) Primary Predicates: • K171769 - Straumann® PURE Ceramic Implants Reference Devices: • K180477 - Straumann® PURE Ceramic Implants • K210336 - Neode… | 2017 |
| † | K180477 | Straumann PURE Ceramic Implant System | 2019 |
| † | K210336 | Neodent Implant System - Zirconia Implant System | 2021 |
| † | K201491 | Neodent Implant System - Zirconia Implant System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K171769.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Straumann® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.
The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241391: Straumann® PURE Ceramic Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241391
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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