510(k) · Cleared
ClearedRenova Internal Hex Implant System
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 Nov 26, 2003 as substantially equivalent to K013227 (Sulzer Dental, Inc., 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 1990. 49 later devices descend from it.
- Decided
- Nov 26, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894595 (1990). 14 ancestors in all. 49 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 1 generation backK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · Recalled
- This deviceK032774 Renova Internal Hex Implant SystemLifecore Biomedical, Inc. · 2003
- Descendant · cites it directly · 43 of its ownK050506 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
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005 · cites it directly43descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −1 | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | 2001 | 2 |
| 0 (this device) | K032774 | Renova Internal Hex Implant System | Lifecore Biomedical, Inc. | 2003 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 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? (2)
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 |
|---|---|---|---|
| * | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| * | K924589 | Restore Self Tapping Dental Implant SystemSummary page 1…Predicate Devices Implants; (KO13227) Lifecore Biomedical, Inc.; Restore Self-Tapping Implant;(K924589) 3. Device Description The Lifecore Biomedical RENOVA Internal Hex Implant System consists of two-stage, root- form tapered and… | 1994 |
What descends from it? (49)
See all 496 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050506 | Primasolo One-Piece Implants & Healing Caps | 2005 | 43 |
| K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection… | 2005 | 40 |
| K110577 | Osseofuse Dental Implant System | 2011 | 4 |
| K121098 | Hero I Dental Implant System | 2013 | 0 |
| K101068 | Accufit Dental Implant Abutments & Screws | 2010 | 0 |
| K072768 | Restore, Stage-1, Renova Primasolo and Primaconnex Dental Implants | 2007 | 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 13 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K050506 (Lifecore Biomedical, Inc., 2005) has gone furthest, with 43 descendants of its own.
- 14 other devices also cite its predicate K013227.
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 Lifecore Biomedical RENOVA™ Internal Hex Implant System is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032774 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032774: Renova Internal Hex 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/K032774
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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