510(k) · Cleared
ClearedEndosseous Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 14, 2010 as substantially equivalent to K970499 (Nobel Biocare Uas, Inc., 1997) and 1 other predicate after a 330-day review. Its family tree reaches back 3 generations to 1993. 10 later devices descend from it.
- Decided
- Oct 14, 2010
- Review
- 330 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925771 (1993). 13 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
- 2 generations backK970499 Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997
- 1 generation backK070182 Zygoma Implant (Immediate Function)Nobel Biocare AB · 2007
- This deviceK093562 Endosseous Dental ImplantSouthern Implants, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK173343 Zygomatic Implant SystemSouthern Implants (Pty), Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK210356 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK192651 ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK153064 Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · cites it directly7descendants
- K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd. · 2018 · cites it directly2descendants
- K210356Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2022 · 2 generations on1descendant
- K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd. · 2020 · 2 generations on1descendant
- K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925771 | Branemark System Titanium Cover Screws | Nobelpharma USA, Inc. | 1993 | — |
| −2 | K970499 | Branemark System Zygomaticus Fixture System | Nobel Biocare Uas, Inc. | 1997 | — |
| −1 | K070182 | Zygoma Implant (Immediate Function) | Nobel Biocare AB | 2007 | — |
| 0 (this device) | K093562 | Endosseous Dental Implant | Southern Implants, Inc. | 2010 | — |
| +1 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +1 | K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +2 | K210356 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2022 | — |
| +2 | K192651 | ZAGA Zygomatic System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K153064 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | 2016 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K970499 | Branemark System Zygomaticus Fixture SystemSummary page 1…e voluntary standards. Southern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium. Predicate Devices: K970499 Branemark System Zygomnatic Implant; K070 182 Nobel Biocare Zygomna Implant Device Description and In… | 1997 |
| * | K070182 | Zygoma Implant (Immediate Function)Summary page 1…ew-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium. Predicate Devices: K970499 Branemark System Zygomnatic Implant; K070 182 Nobel Biocare Zygomna Implant Device Description and Intended Use: The Zygomatic implant is intended… | 2007 |
What descends from it? (10)
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 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K151909 (Noris Medical, Ltd., 2016) has gone furthest, with 7 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. 2010, 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 Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093562: Endosseous Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093562
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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