510(k) · Cleared
ClearedHighness Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Highness Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 31, 2024 as substantially equivalent to K182448 (Megagen Implant Co., Ltd., 2019) after a 266-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Oct 31, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K960026 (1996). 106 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations between
- 3 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 2 generations backK161244 s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. · 2016
- 1 generation backK182448 AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd. · 2019
- This deviceK240383 Highness Implant SystemHighness Co., Ltd. · 2024
Show all 13 generations
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 11 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 10 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 6 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 5 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 4 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 3 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 2 generations backK161244 s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. · 2016
- 1 generation backK182448 AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd. · 2019
- This deviceK240383 Highness Implant SystemHighness Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −12 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −6 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −5 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −4 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −3 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −2 | K161244 | s-Clean OneQ-SL Narrow Implant System | Dentis Co., Ltd. | 2016 | — |
| −1 | K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019 | — |
| 0 (this device) | K240383 | Highness Implant System | Highness Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 9 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K182448 | AnyRidge Octa 1 Implant SystemSummary page 5…ss: II Product Code: DZE, NHA Classification Panel: Dental V. PRIMARY PREDICATE AND REFERENCE DEVICES Primary Predicate Device: K182448, AnyRidge Octa 1 Implant System/ MegaGen Implant Co., Ltd.… | 2019 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K192347 | ST Internal Implant System | 2019 |
| † | K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | 2021 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K160519 | Link Abutment for CEREC | 2016 |
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 28 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 15 of the 106 ancestors have a recall of any class.
- 6 other devices also cite its predicate K182448.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading.
The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240383: Highness Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240383
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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