510(k) · Cleared
ClearedMilo Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra-Lock International · DZE Implant, Endosseous, Root-Form
Cleared on Oct 14, 2005 as substantially equivalent to K041938 (BioHorizons Implant Systems, Inc., 2004) and 2 other predicates after a 179-day review. Its family tree reaches back 9 generations to 1996. 7 later devices descend from it.
- Decided
- Oct 14, 2005
- Review
- 179 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K960026 (1996). 20 ancestors in all, the oldest K925765 (1993). 7 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 5 generations between
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 1 generation backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- This deviceK050970 Milo Dental Implant SystemIntra-Lock International · 2005
- Descendant · cites it directly · 1 of its ownK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
- Descendant · cites it directly · 1 of its ownK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
- Descendant · cites it directly · 1 of its ownK121707 Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012
- Descendant · 2 generations on · 0 of its ownK200386 Z5-BLZ-Systems AG · 2020
- Descendant · cites it directly · 0 of its ownK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
Show all 9 generations
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 7 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 6 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 1 generation backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- This deviceK050970 Milo Dental Implant SystemIntra-Lock International · 2005
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K131701Z5MLB, Z5MLCZ-Systems AG · 2013 · cites it directly1descendant
- K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013 · cites it directly1descendant
- K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012 · cites it directly1descendant
- K200386Z5-BLZ-Systems AG · 2020 · 2 generations on0descendants
- K151970KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −8 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −2 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −1 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| 0 (this device) | K050970 | Milo Dental Implant System | Intra-Lock International | 2005 | — |
| +1 | K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013 | — |
| +1 | K130140 | Intra-Lock OP Dental Implant | Intra-Lock International | 2013 | — |
| +1 | K121707 | Lew Mdi O-Ball Collared Implant, | Park Dental Research Corp. | 2012 | — |
| +2 | K200386 | Z5-BL | Z-Systems AG | 2020 | — |
| +1 | K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K041938 | Maximus OS (Overdenture System)Summary page 1…Company 510(k) Predicate Devices: The Maximus OS T BioHorizons K041938 (Overdenture System) Implant Nobel Direct Nobel Bioca… | 2004 |
| * | K031345 | Nobel Direct, Models 30937, 30938Summary page 1…ns K041938 (Overdenture System) Implant Nobel Direct Nobel Biocare K031345 XiVe® 3.0 Dental Implant FRIADENT GmbH K030639 Sys… | 2003 |
| * | K030639 | Xive 3.0 Dental Implant SystemSummary page 1…Nobel Direct Nobel Biocare K031345 XiVe® 3.0 Dental Implant FRIADENT GmbH K030639 System Device Description: The Intra-Lock MILO TM Dental Implant System consists of machined… | 2003 |
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 9 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K131701 (Z-Systems AG, 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K041938.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
1. MILO TM Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function.
2. MILO T"' Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050970: Milo Dental 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/K050970
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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