510(k) · Cleared
ClearedMaximus 3.0 and OS Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BioHorizons Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 20, 2005 as substantially equivalent to K960026 (BioHorizons Implant Systems, Inc., 1996) and 2 other predicates after an 18-day review. Its family tree reaches back 9 generations to 1996. 104 later devices descend from it.
- Decided
- Sep 20, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K960026 (1996). 15 ancestors in all. 104 later devices descend from it, 1 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 deviceK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- Descendant · cites it directly · 103 of its ownK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 73 of its ownK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- Descendant · 3 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 3 generations on · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
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 deviceK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K093321Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · cites it directly103descendants
- K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010 · 2 generations on73descendants
- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 3 generations on45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 4 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · 3 generations on30descendants
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) | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| +1 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| +2 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| +3 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| +4 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +3 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 12 | 0 |
| 2023 | 11 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K960026 | Biohorizons Dental Implant SystemSummary page 1…stributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K960026, concurrence date March 28, 1996. 2. BioHorizons the Maestro Syste m T M 3.0mm diameter implant, a screw-type… | 1996 |
| * | K032351 | The Maestro System 3.0MM Diameter ImplantSummary page 1…tributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 51 0(k) number K032351, concurrence date October 21, 2003. 3. BioHorizons Maximus OS (Overdenture System) Implant, a screw-type endlosseous… | 2003 |
| * | K041938 | Maximus OS (Overdenture System)Summary page 1…tributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 51 0(k) number K041 938, concurrence date July 22, 2004. Device Description The BioHorizons Maximus 3.0mm and OS implants are machined titanium,… | 2004 |
What descends from it? (104)
See all 1041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 | 103 |
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 1 company; a new generation was cleared every 8 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K093321 (BioHorizons Implant Systems, Inc., 2010) has gone furthest, with 103 descendants of its own.
- 6 other devices also cite its predicate K960026.
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?
The BioHorizons Maximus 3.0 Implants may be used (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion; (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of…
Read the full statement (138 words)
The BioHorizons Maximus 3.0 Implants may be used (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion; (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function; (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
The BioHorizons Maximus OS Implants may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. 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/K052419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052419: Maximus 3.0 and OS Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052419
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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