510(k) · Cleared
ClearedGEN5 and GEN5+ Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Implant Mfg., LLC · DZE Implant, Endosseous, Root-Form
Cleared on Oct 30, 2025 as substantially equivalent to K192221 (Implant Direct Sybron Manufacturing, LLC, 2020) after a 128-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Oct 30, 2025
- Review
- 128 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894595 (1990). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · Recalled
- 4 generations backK073161 Replus Dental Implants (HA)Implant Direct, LLC · 2008
- 3 generations backK080713 Reactive Dental Implant SystemImplant Direct, LLC · 2008
- 2 generations backK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · Recalled
- 1 generation backK192221 Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental…Implant Direct Sybron Manufacturing, LLC · 2020 · Recalled
- This deviceK251938 GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC · 2025
- Descendant · cites it directly · 0 of its ownK261392 TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | 2001 | 2 |
| −4 | K073161 | Replus Dental Implants (HA) | Implant Direct, LLC | 2008 | — |
| −3 | K080713 | Reactive Dental Implant System | Implant Direct, LLC | 2008 | — |
| −2 | K090234 | Spectra System Dental Implants 2008 | Implant Direct, LLC | 2009 | 11 |
| −1 | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants… | Implant Direct Sybron Manufacturing, LLC | 2020 | 2 |
| 0 (this device) | K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025 | — |
| +1 | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Summary page 5…Class II Product Code(s) DZE; NHA Legally Marketed Predicate Device(s) Primary Predicate Device (DZE - Implants) K192221 (Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2,… | 2020 |
| † | K202344 | TiUltra Implants and Xeal Abutments | 2020 |
| † | K241972 | Bluediamond Implant | 2024 |
| † | K161655 | On1 Concept | 2017 |
| † | K052600 | Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled) | 2005 |
| † | K090234 | Spectra System Dental Implants 2008 | 2009 |
| † | K061319 | Spectra System | 2006 |
| † | K060063 | Legacy Abutment System | 2006 |
| † | K143011 | 2014 InterActive/SwishActive System | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261392 | TriActive Dental Implant System | 2026 | 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 35 years and passes through 7 companies; a new generation was cleared every 5.3 years on median.
- 6 of the 20 ancestors have a recall of any class.
- Of its descendants, K261392 (Paragon Implant Mfg., LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K192221.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
GEN5 and GEN5 Implants: GEN5 and GEN5+ implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal…
Read the full statement (131 words)
GEN5 and GEN5 Implants: GEN5 and GEN5+ implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.
Short (<9mmL) Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
GEN5 and GEN5+ Abutment System: The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251938: GEN5 and GEN5+ Dental 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/K251938
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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