510(k) · Cleared
Recalled · Class II · 2018Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecore Biomedical, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 9, 2005 as substantially equivalent to K924589 (Implant Support Systems, Inc., 1994) and 4 other predicates after an 84-day review. Its family tree reaches back 9 generations to 1996. 40 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 9, 2005
- Review
- 84 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 5
- Predicates
- 5
Its longest line of descent runs back 9 generations to K960026 (1996). 34 ancestors in all, the oldest K894595 (1990). 40 later devices descend from it, 11 citing it directly.
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 5 generations between
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 1 generation backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- This deviceK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005
- Descendant · cites it directly · 15 of its ownK101545 Genesis Implant SystemKeystone Dental · 2010 · Recalled
- Descendant · cites it directly · 7 of its ownK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
- 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
Show all 9 generations
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 7 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 6 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 1 generation backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- This deviceK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K101545Genesis Implant SystemKeystone Dental · 2010 · cites it directly15descendants
- K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007 · cites it directly7descendants
- K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006 · cites it directly6descendants
- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · cites it directly5descendants
- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −8 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −2 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −1 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| 0 (this device) | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | — |
| +1 | K101545 | Genesis Implant System | Keystone Dental | 2010 | 3 |
| +1 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| +1 | K062876 | Primaconnex Ceramic Abutments | Lifecore Biomedical, Inc. | 2006 | — |
| +1 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +2 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K924589 | Restore Self Tapping Dental Implant SystemSummary page 1…Self-Tapping Dental Implant System, RD (Lifecore Biomedical, Inc.) (K924589) Restore® Self-Tapping Dental… | 1994 |
| * | K944068 | Restore Self Tapping Dental Implant Syst (5, 5.5,6MM)Summary page 1…ntal Implant System, WVD (Lifecore Biomedical, Inc.) (K944068) *Restore® Self-Tapping Dental… | 1995 |
| * | K951111 | Restore Self Tapping Dental Implant System (3.4MM)Summary page 1…apping Dental Implant System, SD (Lifecore Biomedical, Inc.) (K951 111) *RenovaTM Internal Hex Implant… | 1995 |
| * | K032774 | Renova Internal Hex Implant SystemSummary page 1…vaTM Internal Hex Implant System (Lifecore Biomedical, Inc.) (K032774) *PriMaSoloTM One-Piece Implant… | 2003 |
| * | K050506 | Primasolo One-Piece Implants & Healing CapsSummary page 1…aSoloTM One-Piece Implant System (Lifecore Biomedical, Inc.) (K050506) 3. Device Description The Lifecore Biomedical PrimaConnex Internal Connection Implant System consists of two-stage, root-form… | 2005 |
What descends from it? (40)
See all 4011 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101545 | Genesis Implant System | 2010 | 15 |
| K072241 | Primaconnex Cad/Cam Abutment System | 2007 | 7 |
| K062876 | Primaconnex Ceramic Abutments | 2006 | 6 |
| K160207 | ATLANTIS ISUS Implant Suprastructures | 2016 | 5 |
| K103020 | Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment | 2011 | 4 |
| K101913 | Anthofit OI, Anthofit HE, Ossfit and Axiom | 2011 | 3 |
| K081226 | Simpact Implant System | 2008 | 1 |
| K120089 | Biogenesis Implant System | 2013 | 0 |
| K073032 | Primaconnex SD Esthetic Contour ZI Abutments | 2007 | 0 |
| K072768 | Restore, Stage-1, Renova Primasolo and Primaconnex Dental Implants | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2018 | Class II | Z-2162-2018 | Error in labeling | The implants are mislabeled. |
| Jun 20, 2017 | Class II | Z-0608-2018 | Other | Abutments are unable to accept the final abutment screw |
| Mar 9, 2017 | Class II | Z-1818-2017 | Labeling mix-ups | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants |
| Sep 15, 2016 | Class II | Z-0299-2017 | Packaging process control | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) |
| Mar 11, 2013 | Class II | Z-0973-2013 | Packaging process control | Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K101545 (Keystone Dental, 2010) has gone furthest, with 15 descendants of its own.
- 4 other devices also cite its predicate K924589.
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?
Lifecore Biomedical Dental Implant System implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The PrimaConnex Internal Connection Implant is a threaded internal connection implant. The PrimaConnex Internal Connection Implant is…
Read the full statement (167 words)
Lifecore Biomedical Dental Implant System implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The PrimaConnex Internal Connection Implant is a threaded internal connection implant. The PrimaConnex Internal Connection Implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant into the extraction socket at the time of tooth extraction. The PrimaConnex Internal Connection Implant is intended for immediate provisionalization, non-occlusal load. Immediate Provisionalization defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with or without occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051614
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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