510(k) · Cleared
ClearedModification to the Maestro System
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 Mar 15, 2002 as substantially equivalent to K010458 (BioHorizons Implant Systems, Inc., 2001) and 4 other predicates after a 15-day review. Its family tree reaches back 4 generations to 1996. 333 later devices descend from it.
- Decided
- Mar 15, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K960026 (1996). 5 ancestors in all. 333 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 3 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 2 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 1 generation backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- This deviceK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- Descendant · cites it directly · 332 of its ownK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- Descendant · cites it directly · 331 of its ownK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- Descendant · cites it directly · 313 of its ownK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- Descendant · 2 generations on · 271 of its ownK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
Showing 5 of 333 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 333 · See all- K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002 · cites it directly332descendants
- K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · cites it directly331descendants
- K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003 · cites it directly313descendants
- K041938Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · 2 generations on271descendants
- K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · 2 generations on187descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −3 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −2 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −1 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| 0 (this device) | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| +1 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| +1 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| +1 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| +2 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| +2 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 12 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 10 | 0 |
| 2012 | 10 | 0 |
| 2013 | 13 | 0 |
| 2014 | 15 | 0 |
| 2015 | 13 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 12 | 0 |
| 2019 | 17 | 0 |
| 2020 | 21 | 0 |
| 2021 | 20 | 0 |
| 2022 | 30 | 0 |
| 2023 | 30 | 0 |
| 2024 | 34 | 0 |
| 2025 | 27 | 0 |
| 2026 | 19 | 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 |
|---|---|---|---|
| * | K010458 | The Maestro SystemSummary page 1…BioHorizons Implant Systems Inc. Authorization to legally market the predicate BioHorizons Maestro System implant has been documented under the following 510(k) numbers: K010458, K960026, K964330, K972313, KO10458, K020133. Device Description The proposed Maestro System screw-type dental implant is a mac… | 2001 |
| * | K960026 | Biohorizons Dental Implant SystemSummary page 1…ns Implant Systems Inc. Authorization to legally market the predicate BioHorizons Maestro System implant has been documented under the following 510(k) numbers: K010458, K960026, K964330, K972313, KO10458, K020133. Device Description The proposed Maestro System screw-type dental implant is a machined tit… | 1996 |
| * | K964330 | Biohorizons Dental Implant System (Name Subject to Change)Summary page 1…t Systems Inc. Authorization to legally market the predicate BioHorizons Maestro System implant has been documented under the following 510(k) numbers: K010458, K960026, K964330, K972313, KO10458, K020133. Device Description The proposed Maestro System screw-type dental implant is a machined titanium, sc… | 1997 |
| * | K972313 | The Maestro SystemSummary page 1…Inc. Authorization to legally market the predicate BioHorizons Maestro System implant has been documented under the following 510(k) numbers: K010458, K960026, K964330, K972313, KO10458, K020133. Device Description The proposed Maestro System screw-type dental implant is a machined titanium, screw-form… | 1997 |
| * | K020133 | Modification to the Maestro SystemSummary page 1…n to legally market the predicate BioHorizons Maestro System implant has been documented under the following 510(k) numbers: K010458, K960026, K964330, K972313, KO10458, K020133. Device Description The proposed Maestro System screw-type dental implant is a machined titanium, screw-form implant supplied i… | 2002 |
What descends from it? (333)
See all 3334 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 6 years and passes through 1 company; a new generation was cleared every 10 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K022795 (BioHorizons Implant Systems, Inc., 2002) has gone furthest, with 332 descendants of its own.
- 7 other devices also cite its predicate K010458.
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 Maestro System™ may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020645: Modification to the Maestro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020645
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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