510(k) · Cleared
Recalled · Class II · 2013Modification 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 Feb 26, 2003 as substantially equivalent to K960026 (BioHorizons Implant Systems, Inc., 1996) and 6 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1996. 331 later devices descend from it. It has been recalled once.
- Decided
- Feb 26, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 6 generations to K960026 (1996). 8 ancestors in all. 331 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 5 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 4 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 3 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 2 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 1 generation backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- This deviceK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003
- 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
- Descendant · 4 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
Showing 5 of 331 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 331 · See all- 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
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 4 generations on127descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −5 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −4 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −3 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −2 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −1 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| 0 (this device) | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | — |
| +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 |
| +4 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
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 | 1 | 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? (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 |
|---|---|---|---|
| * | K960026 | Biohorizons Dental Implant SystemSummary page 1…Systems Inc. Authorization to legally market the predicate BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, KO10458, K020133, K020645, and K022795. Device Description The 7mm and 10.5mm length Maestro Syst… | 1996 |
| * | K964330 | Biohorizons Dental Implant System (Name Subject to Change)Summary page 1…nc. Authorization to legally market the predicate BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, KO10458, K020133, K020645, and K022795. Device Description The 7mm and 10.5mm length Maestro System dental… | 1997 |
| * | K972313 | The Maestro SystemSummary page 1…rization to legally market the predicate BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, KO10458, K020133, K020645, and K022795. Device Description The 7mm and 10.5mm length Maestro System dental implants… | 1997 |
| * | K010458 | The Maestro System | 2001 |
| * | K020133 | Modification to the Maestro SystemSummary page 1…y market the predicate BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, KO10458, K020133, K020645, and K022795. Device Description The 7mm and 10.5mm length Maestro System dental implants are a machined titanium… | 2002 |
| * | K020645 | Modification to the Maestro SystemSummary page 1…the predicate BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, KO10458, K020133, K020645, and K022795. Device Description The 7mm and 10.5mm length Maestro System dental implants are a machined titanium, s… | 2002 |
| * | K022795 | Modification to the Maestro SystemSummary page 1…BioHorizons Maestro System dental implants has been documented under the following 510(k) numbers: K960026, K964330, K972313, KO10458, K020133, K020645, and K022795. Device Description The 7mm and 10.5mm length Maestro System dental implants are a machined titanium, screw-form imp… | 2002 |
What descends from it? (331)
See all 3312 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 10, 2013 | Class II | Z-1058-2014 | Mixed-up of materials/components | The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K032351 (BioHorizons Implant Systems, Inc., 2003) has gone furthest, with 313 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 Maestro SystemTM endosseous implants 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 dental retention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030463: 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/K030463
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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