510(k) · Cleared
ClearedZaga Zygomatic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southern Implants (Pty), Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 9, 2022 as substantially equivalent to K192651 (Southern Implants (Pty), Ltd., 2020) after an 83-day review. Its family tree reaches back 19 generations to 1996.
- Decided
- Nov 9, 2022
- Review
- 83 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K960026 (1996). 307 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations between
- 3 generations backK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- 2 generations backK173343 Zygomatic Implant SystemSouthern Implants (Pty), Ltd. · 2018
- 1 generation backK192651 ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd. · 2020
- This deviceK222497 Zaga Zygomatic SystemSouthern Implants (Pty), Ltd. · 2022
Show all 19 generations
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 18 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 17 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 16 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 12 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 11 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 10 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 9 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 8 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 7 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 6 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 5 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 4 generations backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- 3 generations backK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- 2 generations backK173343 Zygomatic Implant SystemSouthern Implants (Pty), Ltd. · 2018
- 1 generation backK192651 ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd. · 2020
- This deviceK222497 Zaga Zygomatic SystemSouthern Implants (Pty), Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −18 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −12 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −11 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −10 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −9 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −8 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −7 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −6 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| −5 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| −4 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| −3 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| −2 | K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| −1 | K192651 | ZAGA Zygomatic System | Southern Implants (Pty), Ltd. | 2020 | — |
| 0 (this device) | K222497 | Zaga Zygomatic System | Southern Implants (Pty), Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 8 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 17 | 0 |
| 1994 | 14 | 0 |
| 1995 | 17 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 8 | 0 |
| 2001 | 16 | 0 |
| 2002 | 18 | 0 |
| 2003 | 17 | 0 |
| 2004 | 20 | 0 |
| 2005 | 14 | 0 |
| 2006 | 18 | 0 |
| 2007 | 19 | 0 |
| 2008 | 13 | 0 |
| 2009 | 12 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K192651 | ZAGA Zygomatic SystemSummary page 4…Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate device is K192651. INDICATIONS FOR USE STATEMENT Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper ja… | 2020 |
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 26 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 37 of the 307 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222497: Zaga Zygomatic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222497
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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