510(k) · Cleared
ClearedNoris Medical Zygomatic Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noris Medical, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 8, 2016 as substantially equivalent to K093562 (Southern Implants, Inc., 2010) and 1 other predicate after a 270-day review. Its family tree reaches back 16 generations to 1996. 7 later devices descend from it.
- Decided
- Apr 8, 2016
- Review
- 270 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K960026 (1996). 259 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations between
- 3 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 2 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 1 generation backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- This deviceK151909 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 · cites it directly · 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 · 0 of its ownK251232 MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252031 Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd. · 2026
Show all 16 generations
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 7 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 6 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 5 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 4 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 3 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 2 generations backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- 1 generation backK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- This deviceK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd. · 2018 · cites it directly2descendants
- K210356Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2022 · cites it directly1descendant
- K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd. · 2020 · 2 generations on1descendant
- K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026 · cites it directly0descendants
- K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −15 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −9 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −8 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −7 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −6 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −5 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −4 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −3 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| −2 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| −1 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| 0 (this device) | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +1 | K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +1 | K210356 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2022 | — |
| +2 | K192651 | ZAGA Zygomatic System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026 | — |
| +1 | K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems, 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K093562 | Endosseous Dental ImplantSummary page 4…roduct Code: DZE/NHA CFR section: 21 CFR§872.3640 Device panel: Dental Legally Marketed Primary Predicate: K093562-SOUTHERN IMPLANTS Inc. Predicate Device: K140440-Noris Medical Ltd. Submitter: Noris Medical L… | 2010 |
| * | K140440 | Noris Medical Dental Implants SystemSummary page 4…21 CFR§872.3640 Device panel: Dental Legally Marketed Primary Predicate: K093562-SOUTHERN IMPLANTS Inc. Predicate Device: K140440-Noris Medical Ltd. Submitter: Noris Medical Ltd. 8 Hataasia street, Nesher 3688808,… | 2014 |
What descends from it? (7)
5 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 20 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 34 of the 259 ancestors have a recall of any class.
- Of its descendants, K173343 (Southern Implants (Pty), Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K093562.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw 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.
Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151909 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151909: Noris Medical Zygomatic 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/K151909
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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