510(k) · Cleared
ClearedAnyRidge Octa 1 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 Oct 9, 2019 as substantially equivalent to K122231 (Megagen Implant Co., Ltd., 2012) and 4 other predicates after a 397-day review. Its family tree reaches back 12 generations to 1996. 9 later devices descend from it.
- Decided
- Oct 9, 2019
- Review
- 397 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K960026 (1996). 105 ancestors in all, the oldest K874590 (1988). 9 later devices descend from it, 7 citing it directly.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 2 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 1 generation backK161244 s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. · 2016
- This deviceK182448 AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK240383 Highness Implant SystemHighness Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK231100 Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing…Proimtech Saglik Urunleri Anonim Sirketi · 2024
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 2 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 1 generation backK161244 s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. · 2016
- This deviceK182448 AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd. · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K203240AccelX AbutmentsIntegrated Dental Systems, LLC · 2021 · cites it directly2descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · 2 generations on1descendant
- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · 3 generations on0descendants
- K240383Highness Implant SystemHighness Co., Ltd. · 2024 · cites it directly0descendants
- K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −2 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −1 | K161244 | s-Clean OneQ-SL Narrow Implant System | Dentis Co., Ltd. | 2016 | — |
| 0 (this device) | K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | 2019 | — |
| +1 | K203240 | AccelX Abutments | Integrated Dental Systems, LLC | 2021 | — |
| +2 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +3 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
| +1 | K240383 | Highness Implant System | Highness Co., Ltd. | 2024 | — |
| +1 | K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap… | Proimtech Saglik Urunleri Anonim Sirketi | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K122231 | Xpeed Any Ridge Internal Implant SystemSummary page 4…Secondary Product Code: NHA ▪ Classification regulation: Class II, 21 CFR 872.3640 4. Predicate Device: ▪ Primary Predicate Device: K122231 - XPEED AnyRidge Internal Implant System ▪ Reference Devices: 1 === P… | 2012 |
| * | K110955 | Anyridge Internal Implant SystemSummary page 5…1 K140878 Straumann Bone Level Tapered Implants K170031 Internal Octa Implant System K153350 IBS Implant system K110955 AnyRidge Internal Implant System K171027 Octa Abutment K072570 NobelActive Multi Unit Abutment K123988 An… | 2011 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 5…ts K170031 Internal Octa Implant System K153350 IBS Implant system K110955 AnyRidge Internal Implant System K171027 Octa Abutment K072570 NobelActive Multi Unit Abutment K123988 AnyOne Internal System K051636 Healing Cap 5. Description: The A… | 2007 |
| * | K123988 | Anyonetm Internal Implant SystemSummary page 5…K153350 IBS Implant system K110955 AnyRidge Internal Implant System K171027 Octa Abutment K072570 NobelActive Multi Unit Abutment K123988 AnyOne Internal System K051636 Healing Cap 5. Description: The AnyRidge Octa 1 Fixture is a substructure of a de… | 2013 |
| * | K161244 | s-Clean OneQ-SL Narrow Implant SystemSummary page 15…Subject Device Predicate Device Reference Device 510(k) K161244 K182448 K153350 Number… | 2016 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
| † | K170031 | Internal Octa Implant System | 2017 |
| † | K153350 | IBS Implant System | 2016 |
| † | K171027 | Dentis Dental Implant System | 2017 |
| † | K051636 | Camlog Dental Implant Abutments, Healing Caps, and Accessories | 2006 |
What descends from it? (9)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203240 | AccelX Abutments | 2021 | 2 |
| K240383 | Highness Implant System | 2024 | 0 |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech… | 2024 | 0 |
| K223339 | Bone Chamber Implant | 2023 | 0 |
| K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | 2021 | 0 |
| K210161 | AnyOne Onestage Implant System | 2021 | 0 |
| K192347 | ST Internal Implant System | 2019 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 15 of the 105 ancestors have a recall of any class.
- Of its descendants, K203240 (Integrated Dental Systems, LLC, 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K122231.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:
- Delayed loading.
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Larger implants are dedicated for the molar region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182448: AnyRidge Octa 1 Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182448
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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