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. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Aug 30, 2002 as substantially equivalent to K010458 (BioHorizons Implant Systems, Inc., 2001) and 6 other predicates after a 7-day review. Its family tree reaches back 5 generations to 1996. 332 later devices descend from it.
- Decided
- Aug 30, 2002
- Review
- 7 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K960026 (1996). 7 ancestors in all. 332 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 4 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 3 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 2 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 1 generation backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- This deviceK022795 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
- Descendant · 3 generations on · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
Showing 5 of 332 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 332 · See all- 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
- K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · 3 generations on141descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −4 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −3 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −2 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −1 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +3 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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…ibuted by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate BioHorizons Maestro System has been documented under 51O(k) numbers K010458, K960026, K964330, K972313, KO10458, KO20133, K020645. The GingiHueTMabutment from Implant Innovations Inc. (3i),… | 2001 |
| * | K960026 | Biohorizons Dental Implant SystemSummary page 1…BioHorizons Implant Systems, Inc. Authorization to legally market the predicate BioHorizons Maestro System has been documented under 51O(k) numbers K010458, K960026, K964330, K972313, KO10458, KO20133, K020645. The GingiHueTMabutment from Implant Innovations Inc. (3i), is a comp… | 1996 |
| * | K964330 | Biohorizons Dental Implant System (Name Subject to Change)Summary page 1…ons Implant Systems, Inc. Authorization to legally market the predicate BioHorizons Maestro System has been documented under 51O(k) numbers K010458, K960026, K964330, K972313, KO10458, KO20133, K020645. The GingiHueTMabutment from Implant Innovations Inc. (3i), is a competitive… | 1997 |
| * | K972313 | The Maestro SystemSummary page 1…tems, Inc. Authorization to legally market the predicate BioHorizons Maestro System has been documented under 51O(k) numbers K010458, K960026, K964330, K972313, KO10458, KO20133, K020645. The GingiHueTMabutment from Implant Innovations Inc. (3i), is a competitive abutment… | 1997 |
| * | K020133 | Modification to the Maestro System | 2002 |
| * | K020645 | Modification to the Maestro SystemSummary page 1…ion to legally market the predicate BioHorizons Maestro System has been documented under 51O(k) numbers K010458, K960026, K964330, K972313, KO10458, KO20133, K020645. The GingiHueTMabutment from Implant Innovations Inc. (3i), is a competitive abutment utilizing a titanium nitri… | 2002 |
| * | K992334 | Endosseous Implants and Abutments- Tin CoatingSummary page 1…g a titanium nitride (Ti-N) coating. Authorization to legally market the predicate 3i abutment and implant system has been documented under 51O(k) number K992334. Device Description The Maestro System is a comprehensive system containing implants, surgical components, and pr… | 1999 |
What descends from it? (332)
See all 3322 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 8 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K030463 (BioHorizons Implant Systems, Inc., 2003) has gone furthest, with 331 descendants of its own.
- 7 other devices also cite its predicate K010458.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The Maestro SystemTM may be used in the mandible or maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022795: Modification to the Maestro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022795
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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