510(k) · Cleared
ClearedPrimasolo One-Piece Implants & Healing Caps
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 Apr 15, 2005 as substantially equivalent to K924589 (Implant Support Systems, Inc., 1994) and 7 other predicates after a 46-day review. Its family tree reaches back 8 generations to 1996. 43 later devices descend from it.
- Decided
- Apr 15, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 8 generations to K960026 (1996). 33 ancestors in all, the oldest K894595 (1990). 43 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 6 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 5 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 2 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 1 generation backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- This deviceK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- Descendant · cites it directly · 40 of its ownK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 15 of its ownK101545 Genesis Implant SystemKeystone Dental · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK072241 Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK062876 Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Lifecore Biomedical, Inc. · 2005 · cites it directly40descendants
- K101545Genesis Implant SystemKeystone Dental · 2010 · 2 generations on15descendants
- K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007 · 2 generations on7descendants
- K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006 · 2 generations on6descendants
- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −7 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −5 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −2 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −1 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| 0 (this device) | 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 |
| +2 | K101545 | Genesis Implant System | Keystone Dental | 2010 | 3 |
| +2 | K072241 | Primaconnex Cad/Cam Abutment System | Lifecore Biomedical, Inc. | 2007 | — |
| +2 | K062876 | Primaconnex Ceramic Abutments | Lifecore Biomedical, Inc. | 2006 | — |
| +2 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 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? (8)
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…ng 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…ng Dental Implant System, WD (Lifecore Biomedical, Inc.) (K944068) * Restore® Self-Tapping Dental… | 1995 |
| * | K951111 | Restore Self Tapping Dental Implant System (3.4MM)Summary page 1…ng Dental Implant System, SD (Lifecore Biomedical, Inc.) (K951 11 1) * Altiva Immediate Function Dental… | 1995 |
| * | K992512 | Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation…Summary page 1…a Immediate Function Dental Implant (Altiva Corporation) (K99251 2) * Replace® One Piece Implant… | 1999 |
| * | K023952 | Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteSummary page 1…Replace® One Piece Implant (Nobel Biocare USA, Inc.) (K023952) * Nobel Direct (Nobel Biocare USA,… | 2003 |
| * | K031345 | Nobel Direct, Models 30937, 30938Summary page 1…(K023952) * Nobel Direct (Nobel Biocare USA, Inc.) (K031345) * Biohorizons the Maestro System rm… | 2003 |
| * | K032351 | The Maestro System 3.0MM Diameter ImplantSummary page 1….0mm Diameter Implant (Biohorizons Implant System, Inc.) (K032351) Page 31 Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notific… | 2003 |
| * | K032774 | Renova Internal Hex Implant SystemSummary page 2…RenovaTM Internal Hex Implant System (Lifecore Biomedical, Inc.) (K032774) 3. Device Description The Lifecore PrimaSoloTM One-Piece Implant System is a one-piece implant incorporating both the implan… | 2003 |
What descends from it? (43)
See all 433 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 4 of the 33 ancestors have a recall of any class.
- Of its descendants, K051614 (Lifecore Biomedical, Inc., 2005) has gone furthest, with 40 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. Specific Intended Uses: The PrimaSolo One-Piece (3.5 - 5.0mm) Implant is a threaded one-piece implant with an integrated abutment…
Read the full statement (173 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.
Specific Intended Uses: The PrimaSolo One-Piece (3.5 - 5.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and cemented restorations. The PrimaSolo One-Piece Implant is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.
The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050506: Primasolo One-Piece Implants & Healing Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050506
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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