510(k) · Cleared
ClearedZirconia Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on Mar 6, 2007 as substantially equivalent to K023952 (Nobel Biocare Uas, Inc., 2003) and 1 other predicate after a 237-day review. Its family tree reaches back 1 generation to 2002. 30 later devices descend from it.
- Decided
- Mar 6, 2007
- Review
- 237 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022562 (2002). 2 ancestors in all. 30 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
- This deviceK061971 Zirconia ImplantNobel Biocare AB · 2007
- Descendant · cites it directly · 27 of its ownK093595 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
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K093595Ceraroot Implant SystemOral Iceberg S.L. · 2011 · cites it directly27descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| 0 (this device) | K061971 | Zirconia Implant | Nobel Biocare AB | 2007 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 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 |
|---|---|---|---|
| * | K023952 | Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteSummary page 1…mplant (21 CFR 872.3640) Trade or Proprietary or Model Name: Zirconia Implant Legally Marketed Device(s): Replace One Piece Implant (K023952) Branemark System Dental Implant (K022562) Device Description: Nobel Biocare Zirconia I… | 2003 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…Zirconia Implant Legally Marketed Device(s): Replace One Piece Implant (K023952) Branemark System Dental Implant (K022562) Device Description: Nobel Biocare Zirconia Implants are threaded, root-form dental implants intended for use in the upper and/… | 2002 |
What descends from it? (30)
See all 304 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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Nobel Biocare's Zirconia Implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Zirconia Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare Zirconia Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manual are satisfied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061971 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061971: Zirconia Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061971
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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