510(k) · Cleared
ClearedNobelZygoma 0°
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 Dec 4, 2018 as substantially equivalent to K161598 (Nobel Biocare AB, 2017) after a 29-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Dec 4, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K925771 (1993). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
- 4 generations backK970499 Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK070182 Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007
- 2 generations backK152093 NobelZygoma 45°Nobel Biocare AB · 2016
- 1 generation backK161598 NobelZygoma 0°Nobel Biocare AB · 2017
- This deviceK183069 NobelZygoma 0°Nobel Biocare AB · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925771 | Branemark System Titanium Cover Screws | Nobelpharma USA, Inc. | 1993 | — |
| −4 | K970499 | Branemark System Zygomaticus Fixture System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K070182 | Zygoma Implant (Immediate Function) | Nobel Biocare AB | 2007 | — |
| −2 | K152093 | NobelZygoma 45° | Nobel Biocare AB | 2016 | — |
| −1 | K161598 | NobelZygoma 0° | Nobel Biocare AB | 2017 | — |
| 0 (this device) | K183069 | NobelZygoma 0° | Nobel Biocare AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K161598 | NobelZygoma 0°Summary page 4…on Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Primary Product Code: DZE PREDICATE DEVICE Primary predicate Nobel Biocare – NobelZygoma 0o (K161598) DEVICE DESCRIPTION Implants: Nobel Biocare’s NobelZygoma 0° implants are threaded, root-form titanium dental implants intende… | 2017 |
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 25 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K161598.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
NobelZygoma 0° implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183069: NobelZygoma 0°.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183069
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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