510(k) · Cleared
ClearedThe Maestro System 3.0MM Diameter Implant
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 Oct 21, 2003 as substantially equivalent to K960026 (BioHorizons Implant Systems, Inc., 1996) and 11 other predicates after an 83-day review. Its family tree reaches back 7 generations to 1996. 313 later devices descend from it.
- Decided
- Oct 21, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 7 generations to K960026 (1996). 13 ancestors in all. 313 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 5 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 4 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 2 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 1 generation backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- This deviceK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- Descendant · cites it directly · 271 of its ownK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- Descendant · cites it directly · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 2 generations on · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- Descendant · 3 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 4 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
Showing 5 of 313 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 313 · See all- K041938Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · cites it directly271descendants
- K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly187descendants
- K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · 2 generations on141descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 3 generations on127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 4 generations on123descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −6 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −5 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −4 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −2 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −1 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| 0 (this device) | 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 |
| +1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +2 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| +3 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +4 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 10 | 0 |
| 2014 | 14 | 0 |
| 2015 | 11 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 10 | 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? (12)
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…distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant system has been documented under 51O(k) numbers K960026, K964330, K972313, K010458, K020133, K020645, KO22795 and K030463. 2. The Altiva Natural Tooth Replacement (NTR)… | 1996 |
| * | K964330 | Biohorizons Dental Implant System (Name Subject to Change)Summary page 1…d by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant system has been documented under 51O(k) numbers K960026, K964330, K972313, K010458, K020133, K020645, KO22795 and K030463. 2. The Altiva Natural Tooth Replacement (NTR) System 3.3mm diamet… | 1997 |
| * | K972313 | The Maestro SystemSummary page 1…orizons Implant Systems, Inc. Authorization to legally market the predicate implant system has been documented under 51O(k) numbers K960026, K964330, K972313, K010458, K020133, K020645, KO22795 and K030463. 2. The Altiva Natural Tooth Replacement (NTR) System 3.3mm diameter implan… | 1997 |
| * | K010458 | The Maestro SystemSummary page 1…mplant Systems, Inc. Authorization to legally market the predicate implant system has been documented under 51O(k) numbers K960026, K964330, K972313, K010458, K020133, K020645, KO22795 and K030463. 2. The Altiva Natural Tooth Replacement (NTR) System 3.3mm diameter implant, a… | 2001 |
| * | K020133 | Modification to the Maestro SystemSummary page 1…stems, Inc. Authorization to legally market the predicate implant system has been documented under 51O(k) numbers K960026, K964330, K972313, K010458, K020133, K020645, KO22795 and K030463. 2. The Altiva Natural Tooth Replacement (NTR) System 3.3mm diameter implant, a one… | 2002 |
| * | K020645 | Modification to the Maestro SystemSummary page 1…c. Authorization to legally market the predicate implant system has been documented under 51O(k) numbers K960026, K964330, K972313, K010458, K020133, K020645, KO22795 and K030463. 2. The Altiva Natural Tooth Replacement (NTR) System 3.3mm diameter implant, a one-piece sc… | 2002 |
| * | K022795 | Modification to the Maestro System | 2002 |
| * | K030463 | Modification to the Maestro SystemSummary page 1…egally market the predicate implant system has been documented under 51O(k) numbers K960026, K964330, K972313, K010458, K020133, K020645, KO22795 and K030463. 2. The Altiva Natural Tooth Replacement (NTR) System 3.3mm diameter implant, a one-piece screw-type endosseous i… | 2003 |
| * | K992512 | Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation…Summary page 1…crew-type endosseous implant for long-term applications manufactured and distributed by Altiva Corporation and cleared for market under 51O(k) number K992512. 3, The Sendax Mini Dental Implant (MDI) 1.8mm diameter implant, a one-piece screw- type endosseous implant for t… | 1999 |
| * | K972351 | Sendax Mdi (Mini Dental Implant)Summary page 1…ous implant for transitional and long-term applications manufactured and distributed by lmtec Corporation and cleared for market under 510(k) numbers K972351, K990983 and K023067. Device Description The BioHorizons Maestro System 3.0mm diameter dental implant is a machined… | 1997 |
| * | K990983 | Modification to Imtec Sendax MdiSummary page 1…nt for transitional and long-term applications manufactured and distributed by lmtec Corporation and cleared for market under 510(k) numbers K972351, K990983 and K023067. Device Description The BioHorizons Maestro System 3.0mm diameter dental implant is a machined titanium,… | 1999 |
| * | K023067 | Imtec Sendax Mdi ORTHO6 and ORTHO8Summary page 1…itional and long-term applications manufactured and distributed by lmtec Corporation and cleared for market under 510(k) numbers K972351, K990983 and K023067. Device Description The BioHorizons Maestro System 3.0mm diameter dental implant is a machined titanium, screw-form… | 2002 |
What descends from it? (313)
See all 3137 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041938 | Maximus OS (Overdenture System) | 2004 | 271 |
| K063364 | Alpha Bio Dental Implant System | 2007 | 187 |
| K052419 | Maximus 3.0 and OS Implants | 2005 | 104 |
| K050506 | Primasolo One-Piece Implants & Healing Caps | 2005 | 43 |
| K080115 | I-Mini Dental Implant | 2008 | 1 |
| K121281 | Simpli Simpler Implant System | 2013 | 0 |
| K112758 | Kat Implants System One-Piece Implants 2.5X10 | 2012 | 0 |
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 7 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K041938 (BioHorizons Implant Systems, Inc., 2004) has gone furthest, with 271 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 Maestro System 3.0 mm Diameter Implant 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032351: The Maestro System 3.0MM Diameter Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032351
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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