510(k) · Cleared
ClearedZygoma Implant (Immediate Function)
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 Apr 4, 2007 as substantially equivalent to K970499 (Nobel Biocare Uas, Inc., 1997) and 2 other predicates after a 75-day review. Its family tree reaches back 2 generations to 1993. 19 later devices descend from it.
- Decided
- Apr 4, 2007
- Review
- 75 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K925771 (1993). 12 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
- 1 generation backK970499 Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997
- This deviceK070182 Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007
- Descendant · cites it directly · 10 of its ownK093562 Endosseous Dental ImplantSouthern Implants, Inc. · 2010
- Descendant · cites it directly · 8 of its ownK141777 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 2 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK152093 NobelZygoma 45°Nobel Biocare AB · 2016
- Descendant · 2 generations on · 2 of its ownK190718 Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K093562Endosseous Dental ImplantSouthern Implants, Inc. · 2010 · cites it directly10descendants
- K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · cites it directly8descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 2 generations on7descendants
- K152093NobelZygoma 45°Nobel Biocare AB · 2016 · cites it directly3descendants
- K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925771 | Branemark System Titanium Cover Screws | Nobelpharma USA, Inc. | 1993 | — |
| −1 | K970499 | Branemark System Zygomaticus Fixture System | Nobel Biocare Uas, Inc. | 1997 | — |
| 0 (this device) | K070182 | Zygoma Implant (Immediate Function) | Nobel Biocare AB | 2007 | — |
| +1 | K093562 | Endosseous Dental Implant | Southern Implants, Inc. | 2010 | — |
| +1 | K141777 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +2 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +1 | K152093 | NobelZygoma 45° | Nobel Biocare AB | 2016 | — |
| +2 | K190718 | Zygomatic Implants | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K970499 | Branemark System Zygomaticus Fixture SystemSummary page 1…nt (21 CFR 872.3640) Trade or Proprietary or Model Name: Zygoma Implant Legally Marketed Device(s): Branemark System Zygomaticus Fixture System (K970499) Zygoma TiUnite (K050641) Zygoma Angled Abutments (K052885) Device Desc… | 1997 |
| * | K050641 | Zygoma TiuniteSummary page 1…me: Zygoma Implant Legally Marketed Device(s): Branemark System Zygomaticus Fixture System (K970499) Zygoma TiUnite (K050641) Zygoma Angled Abutments (K052885) Device Description: The Zygoma Implant is a titanium endosseous… | 2005 |
| * | K052885 | Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM…Summary page 1…evice(s): Branemark System Zygomaticus Fixture System (K970499) Zygoma TiUnite (K050641) Zygoma Angled Abutments (K052885) Device Description: The Zygoma Implant is a titanium endosseous implant longer than traditional endosseous implants. The Zygom… | 2005 |
What descends from it? (19)
See all 193 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 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K093562 (Southern Implants, Inc., 2010) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K970499.
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 Zygoma 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 Zygoma Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070182: Zygoma Implant (Immediate Function).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070182
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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