510(k) · Cleared
ClearedStraumann PURE Ceramic Implant System
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 Jan 4, 2019 as substantially equivalent to K171769 (Straumann USA, LLC (On Behalf of Institut Straumann Ag), 2017) after a 316-day review. Its family tree reaches back 6 generations to 2002. 6 later devices descend from it.
- Decided
- Jan 4, 2019
- Review
- 316 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. 6 later devices descend from it, 3 citing it directly.
- 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 deviceK180477 Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019
- Descendant · cites it directly · 2 of its ownK190654 Straumann CI RD Ceramic Healing CapsInstitut Straumann AG · 2019
- Descendant · cites it directly · 1 of its ownK231803 Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2023
- Descendant · 2 generations on · 1 of its ownK192893 Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020
- Descendant · cites it directly · 1 of its ownK192053 W Zirconia ImplantsTav Medical, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190654Straumann CI RD Ceramic Healing CapsInstitut Straumann AG · 2019 · cites it directly2descendants
- K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2023 · cites it directly1descendant
- K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020 · 2 generations on1descendant
- K192053W Zirconia ImplantsTav Medical, Ltd. · 2019 · cites it directly1descendant
- K232383iPhysio® SystemEuroteknika · 2025 · 2 generations on0descendants
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) | K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019 | — |
| +1 | K190654 | Straumann CI RD Ceramic Healing Caps | Institut Straumann AG | 2019 | — |
| +1 | K231803 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023 | — |
| +2 | K192893 | Straumann Ceramic Healing Abutments | Institut Straumann AG | 2020 | — |
| +1 | K192053 | W Zirconia Implants | Tav Medical, Ltd. | 2019 | — |
| +2 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K171769 | Straumann PURE Ceramic ImplantsSummary page 4…21 CFR 872.3640 Regulatory Class: II Primary Product Code: DZE Secondary Product Code: NHA 5.3 Predicate Device Primary Predicate: K171769 – Straumann PURE Ceramic Implants Reference Devices: K151328 – PURE Ceramic Implants K163043 – Zeram… | 2017 |
| † | K151328 | PURE Ceramic Implants | 2016 |
| † | K163043 | Zeramex P6 Dental Implant System | 2016 |
| † | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | 2007 |
| † | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | 2013 |
| † | K122192 | NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary… | 2012 |
| † | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase… | 2015 |
| † | K170354 | Straumann Variobase Abutments | 2017 |
| † | K170356 | Straumann Variobase Abutments | 2017 |
| † | K173379 | Straumann Variobase for Crown AS | 2018 |
What descends from it? (6)
3 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 17 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K190654 (Institut Straumann AG, 2019) has gone furthest, with 2 descendants of its own.
- 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. 2019, 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?
Straumann PURE Ceramic Implant: The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components. Closure and healing caps: Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect…
Read the full statement (226 words)
Straumann PURE Ceramic Implant:
The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
Closure and healing caps:
Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.
Temporary Abutments:
The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.
CI RD Straumann PUREbase Abutments:
CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180477: Straumann PURE Ceramic 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/K180477
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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