510(k) · Cleared
Recalled · Class II · 2018Genesis Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keystone Dental · DZE Implant, Endosseous, Root-Form
Cleared on Oct 28, 2010 as substantially equivalent to K051614 (Lifecore Biomedical, Inc., 2005) and 5 other predicates after a 147-day review. Its family tree reaches back 10 generations to 1996. 15 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 28, 2010
- Review
- 147 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 3
- Predicates
- 6
Its longest line of descent runs back 10 generations to K960026 (1996). 122 ancestors in all, the oldest K781060 (1978). 15 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations between
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 1 generation backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- This deviceK101545 Genesis Implant SystemKeystone Dental · 2010
- Descendant · cites it directly · 5 of its ownK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- Descendant · 3 generations on · 2 of its ownK213449 DS Implants abutments provided with the EV connectionDentsply Sirona · 2021
- Descendant · cites it directly · 2 of its ownK123512 Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG · 2013
- Descendant · cites it directly · 2 of its ownK123415 Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG · 2013
Show all 10 generations
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 1 generation backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- This deviceK101545 Genesis Implant SystemKeystone Dental · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · cites it directly5descendants
- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · 2 generations on4descendants
- K213449DS Implants abutments provided with the EV connectionDentsply Sirona · 2021 · 3 generations on2descendants
- K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG · 2013 · cites it directly2descendants
- K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −9 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −3 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −2 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −1 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| 0 (this device) | K101545 | Genesis Implant System | Keystone Dental | 2010 | — |
| +1 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +2 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| +3 | K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021 | — |
| +1 | K123512 | Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM | Biodenta Swiss AG | 2013 | — |
| +1 | K123415 | Biodenta Dental Implant System- Bone Level Tapered | Biodenta Swiss AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 11 | 0 |
| 2003 | 11 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Summary page 1…(Predicate Devices) Device Name Manufacturer 510(k) Number(s) PrimaConnex"' Internal Connection Implant System Keystone Dental K051614 Straumann"' Dental Implant System Straumann K053088, K061 176 NanoTite" Dental Implantsp… | 2005 |
| * | K053088 | Slactive ImplantsSummary page 1…510(k) Number(s) PrimaConnex"' Internal Connection Implant System Keystone Dental K051614 Straumann"' Dental Implant System Straumann K053088, K061 176 NanoTite" Dental Implantsp Biomiet 3i K062432 TiU-nite-`'NobelActive~ Implants… | 2006 |
| * | K061176 | Straumann Dental ImplantsSummary page 1…Number(s) PrimaConnex"' Internal Connection Implant System Keystone Dental K051614 Straumann"' Dental Implant System Straumann K053088, K061 176 NanoTite" Dental Implantsp Biomiet 3i K062432 TiU-nite-`'NobelActive~ Implants… | 2006 |
| * | K062432 | Nanotite Dental ImplantsSummary page 1…Straumann"' Dental Implant System Straumann K053088, K061 176 NanoTite" Dental Implantsp Biomiet 3i K062432 TiU-nite-`'NobelActive~ Implants Nobel Biocare K050705, K071370 Device Description The Genesis Impl… | 2007 |
| * | K050705 | Tiunite ImplantsSummary page 1…K061 176 NanoTite" Dental Implantsp Biomiet 3i K062432 TiU-nite-`'NobelActive~ Implants Nobel Biocare K050705, K071370 Device Description The Genesis Implant System includes implants, abutments, and associated surgical, restorative and de… | 2005 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 1…NanoTite" Dental Implantsp Biomiet 3i K062432 TiU-nite-`'NobelActive~ Implants Nobel Biocare K050705, K071370 Device Description The Genesis Implant System includes implants, abutments, and associated surgical, restorative and dental labo… | 2007 |
What descends from it? (15)
See all 157 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160207 | ATLANTIS ISUS Implant Suprastructures | 2016 | 5 |
| K123512 | Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM | 2013 | 2 |
| K123415 | Biodenta Dental Implant System- Bone Level Tapered | 2013 | 2 |
| K223814 | Genesis ACTIVE Implant System | 2023 | 1 |
| K212962 | TRELLIS™ SI Joint Fusion System | 2022 | 0 |
| K201334 | Keystone Dental XL Dental Implant System | 2020 | 0 |
| K113003 | Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant… | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2018 | Class II | Z-1485-2018 | Error in labeling | The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette. |
| Jul 5, 2011 | Class II | Z-0923-2013 | Mixed-up of materials/components | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment, |
| Jul 5, 2011 | Class II | Z-0924-2013 | Mixed-up of materials/components | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 16 of the 122 ancestors have a recall of any class.
- Of its descendants, K160207 (Dentsply International, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K051614.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or hilly edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient chewing fuinction and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101545 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101545: Genesis Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101545
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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