510(k) · Cleared
ClearedMegaGen Zygoma Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 18, 2026 as substantially equivalent to K151909 (Noris Medical, Ltd., 2016) and 1 other predicate after a 422-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Jun 18, 2026
- Review
- 422 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K960026 (1996). 261 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- 2 generations backK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- 1 generation backK210356 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2022
- This deviceK251232 MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 8 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 7 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 6 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 5 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 4 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 3 generations backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- 2 generations backK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- 1 generation backK210356 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2022
- This deviceK251232 MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −8 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −7 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −6 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −5 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| −4 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| −3 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| −2 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| −1 | K210356 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2022 | — |
| 0 (this device) | K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026 | — |
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 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 13 | 0 |
| 1994 | 14 | 0 |
| 1995 | 14 | 0 |
| 1996 | 14 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 8 | 0 |
| 2001 | 13 | 0 |
| 2002 | 15 | 0 |
| 2003 | 15 | 0 |
| 2004 | 16 | 0 |
| 2005 | 11 | 0 |
| 2006 | 16 | 0 |
| 2007 | 15 | 0 |
| 2008 | 9 | 0 |
| 2009 | 9 | 0 |
| 2010 | 5 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K151909 | Noris Medical Zygomatic Dental Implant SystemSummary page 5…DZE • Secondary Product Code: NHA 4. Predicate Device • Primary Predicate Device: K151909 - Noris Medical Zygomatic Dental Implant System • Reference Device: K192651- ZAGA Zyg… | 2016 |
| * | K210356 | Noris Medical Dental Implants SystemSummary page 5…K212785 - GM Helix LG Neodent Implant System K160119 - NobelSpeedy® Groovy K241972- BLUEDIAMOND IMPLANT K210356 - Noris Medical Dental Implant System K242030 - MegaGen Dental Implant Abutment K2334… | 2022 |
| † | K192651 | ZAGA Zygomatic System | 2020 |
| † | K232099 | Neodent Implant System - GM Zygomatic Implant System | 2023 |
| † | K190491 | Blue Sky Bio Zygomatic Implant System | 2019 |
| † | K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio… | 2022 |
| † | K160119 | NobelSpeedy Groovy | 2016 |
| † | K241972 | Bluediamond Implant | 2024 |
| † | K242030 | MegaGen Dental Implant Abutment | 2025 |
| † | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary… | 2024 |
| † | K190958 | Neodent Implant System | 2019 |
| † | K122231 | Xpeed Any Ridge Internal Implant System | 2012 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | 2022 |
| † | K150537 | MiNi Internal Implant System | 2015 |
| † | K203554 | AnyOne External Implant System | 2021 |
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 30 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 34 of the 261 ancestors have a recall of any class.
- 4 other devices also cite its predicate K151909.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Zygoma Dental Implant system is intended to replace missing tooth/teeth by surgical installation in the zygoma region for supporting prosthetic devices that may aid in restoring the patient’s chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The Dental implants are only…
Read the full statement (109 words)
Zygoma Dental Implant system is intended to replace missing tooth/teeth by surgical installation in the zygoma region for supporting prosthetic devices that may aid in restoring the patient’s chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The Dental implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
Zygomatic Dental Implants are intended to be implanted in the upper jaw arch to provide support for fixed on removable prosthetic devices in patients with partially or fully edentulous maxilla.
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/K251232 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251232: MegaGen Zygoma Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251232
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026