510(k) · Cleared
ClearedPrima Plus Conical Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keystone Dental, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 9, 2024 as substantially equivalent to K223814 (Keystone Dental, Inc., 2023) after a 91-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Jul 9, 2024
- Review
- 91 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K960026 (1996). 124 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 2 generations backK101545 Genesis Implant SystemKeystone Dental · 2010 · Recalled
- 1 generation backK223814 Genesis ACTIVE Implant SystemKeystone Dental, Inc. · 2023
- This deviceK240966 Prima Plus Conical Implant SystemKeystone Dental, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 3 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 2 generations backK101545 Genesis Implant SystemKeystone Dental · 2010 · Recalled
- 1 generation backK223814 Genesis ACTIVE Implant SystemKeystone Dental, Inc. · 2023
- This deviceK240966 Prima Plus Conical Implant SystemKeystone Dental, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −3 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| −2 | K101545 | Genesis Implant System | Keystone Dental | 2010 | 3 |
| −1 | K223814 | Genesis ACTIVE Implant System | Keystone Dental, Inc. | 2023 | — |
| 0 (this device) | K240966 | Prima Plus Conical Implant System | Keystone Dental, Inc. | 2024 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K223814 | Genesis ACTIVE Implant SystemSummary page 5…and design principals to the following legally marketed predicate device. 510(k) Predicate Device Name Company Name K223814 Genesis Active Implant System Keystone Dental Inc. The following reference devices are used… | 2023 |
| † | K220200 | Paltop Conical Implant System | 2022 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 17 of the 124 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Prima PlusTM Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus TM Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima PlusTM Conical implants are intended for placement following natural tooth loss or for…
Read the full statement (115 words)
The Prima PlusTM Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus TM Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima PlusTM Conical 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.
All digitally designed custom abutments for use with Prima Plus TM Conical Implant System implants are to be sent to a Keystone Dental validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240966 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240966: Prima Plus Conical Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240966
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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