510(k) · Cleared
ClearedPURE Ceramic Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZE Implant, Endosseous, Root-Form
Cleared on Jan 11, 2016 as substantially equivalent to K120793 (Z-Systems AG, 2012) after a 238-day review. Its family tree reaches back 4 generations to 2002. 12 later devices descend from it.
- Decided
- Jan 11, 2016
- Review
- 238 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022562 (2002). 8 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
- 3 generations backK061971 Zirconia ImplantNobel Biocare AB · 2007
- 2 generations backK093595 Ceraroot Implant SystemOral Iceberg S.L. · 2011
- 1 generation backK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
- This deviceK151328 PURE Ceramic ImplantsStraumann USA · 2016
- Descendant · cites it directly · 8 of its ownK171769 Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
- Descendant · 2 generations on · 6 of its ownK180477 Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019
- Descendant · cites it directly · 4 of its ownK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK190654 Straumann CI RD Ceramic Healing CapsInstitut Straumann AG · 2019
- Descendant · 3 generations on · 1 of its ownK231803 Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017 · cites it directly8descendants
- K180477Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019 · 2 generations on6descendants
- K172668W Zirconia ImplantsTav Medical, Ltd. · 2018 · cites it directly4descendants
- K190654Straumann CI RD Ceramic Healing CapsInstitut Straumann AG · 2019 · 3 generations on2descendants
- K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| −3 | K061971 | Zirconia Implant | Nobel Biocare AB | 2007 | — |
| −2 | K093595 | Ceraroot Implant System | Oral Iceberg S.L. | 2011 | — |
| −1 | K120793 | Z-LOOK3 Evo SLM | Z-Systems AG | 2012 | — |
| 0 (this device) | K151328 | PURE Ceramic Implants | Straumann USA | 2016 | — |
| +1 | K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017 | — |
| +2 | K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019 | — |
| +1 | K172668 | W Zirconia Implants | Tav Medical, Ltd. | 2018 | — |
| +3 | K190654 | Straumann CI RD Ceramic Healing Caps | Institut Straumann AG | 2019 | — |
| +3 | K231803 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K120793 | Z-LOOK3 Evo SLMSummary page 5…K151328 Straumann® PURE Ceramic Implants 1.3 Predicate Device 1.3.1 Primary Predicate Device • K120793, Z-Look3 Evo SLM 1.3.2 Reference Predicate Device(s) • K033922, Modification to ITI Dental Implant System • K0… | 2012 |
| † | K033922 | Modification to Iti Dental Implant System | 2004 |
| † | K062129 | P.0004 Implants | 2006 |
| † | K123784 | Straumann Dental Implant System | 2013 |
| † | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | 2011 |
| † | K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective Caps | 2007 |
| † | K080286 | Cementable Abuntments; Temporary Copings; Protective Caps | 2008 |
What descends from it? (12)
See all 123 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 14 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K171769 (Straumann USA, LLC (On Behalf of Institut Straumann Ag), 2017) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K120793.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 (Monotype) 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. The Straumann® PURE Ceramic Implant Protective Cap is…
Read the full statement (114 words)
The Straumann® PURE Ceramic Implant (Monotype) 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.
The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 6 months.
Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151328 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151328: PURE Ceramic Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151328
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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