510(k) · Cleared
ClearedThe Prodigy System Dental 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 16, 2004 as substantially equivalent to K960026 (BioHorizons Implant Systems, Inc., 1996) and 3 other predicates after an 8-day review. Its family tree reaches back 7 generations to 1996. 120 later devices descend from it.
- Decided
- Sep 16, 2004
- Review
- 8 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K960026 (1996). 9 ancestors in all. 120 later devices descend from it, 6 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 deviceK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
- Descendant · cites it directly · 111 of its ownK073268 Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 103 of its ownK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- Descendant · cites it directly · 77 of its ownK053152 Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 76 of its ownK073282 Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008
- Descendant · 2 generations on · 73 of its ownK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 120 · See all- K073268Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · cites it directly111descendants
- K093321Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · 2 generations on103descendants
- K053152Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. · 2005 · cites it directly77descendants
- K073282Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008 · 2 generations on76descendants
- K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010 · 2 generations on73descendants
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) | K042429 | The Prodigy System Dental Implants | BioHorizons Implant Systems, Inc. | 2004 | — |
| +1 | K073268 | Biohorizons Internal Implant System | BioHorizons Implant Systems, Inc. | 2008 | 1 |
| +2 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| +1 | K053152 | Biohorizons Single-Stage Implant | BioHorizons Implant Systems, Inc. | 2005 | 1 |
| +2 | K073282 | Biohorizons Single-Stage Implant System | BioHorizons Implant Systems, Inc. | 2008 | — |
| +2 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 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? (4)
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…ed and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) numbers K960026, concurrence date March 28, 1996; K010458, February 15, 2001; K020133, January 15, 2002; and K030463, February 10, 2003.… | 1996 |
| * | K010458 | The Maestro SystemSummary page 1…Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) numbers K960026, concurrence date March 28, 1996; K010458, February 15, 2001; K020133, January 15, 2002; and K030463, February 10, 2003. Device Description The Prodigy Syste… | 2001 |
| * | K020133 | Modification to the Maestro SystemSummary page 1…o legally market the predicate implant device has been documented under 510(k) numbers K960026, concurrence date March 28, 1996; K010458, February 15, 2001; K020133, January 15, 2002; and K030463, February 10, 2003. Device Description The Prodigy System dental implants are machined tita… | 2002 |
| * | K030463 | Modification to the Maestro SystemSummary page 1…implant device has been documented under 510(k) numbers K960026, concurrence date March 28, 1996; K010458, February 15, 2001; K020133, January 15, 2002; and K030463, February 10, 2003. Device Description The Prodigy System dental implants are machined titanium, screw-form implants… | 2003 |
What descends from it? (120)
See all 1206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073268 | Biohorizons Internal Implant System | 2008 | 111 |
| K053152 | Biohorizons Single-Stage Implant | 2005 | 77 |
| K073258 | Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon… | 2008 | 3 |
| K073540 | Atlantis Abutment in Zirconia for Biohorizons Implant | 2008 | 1 |
| K131526 | Sfi-Bar | 2013 | 0 |
| K061567 | Biohorizons Ceramic Abutment | 2006 | 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 8 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K073268 (BioHorizons Implant Systems, Inc., 2008) has gone furthest, with 111 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 Prodigy System 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/K042429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042429: The Prodigy System Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042429
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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