510(k) · Cleared
ClearedNizPlant 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 Dec 23, 2025 as substantially equivalent to K090234 (Implant Direct, LLC, 2009) after a 307-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Dec 23, 2025
- Review
- 307 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894595 (1990). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · Recalled
- 3 generations backK073161 Replus Dental Implants (HA)Implant Direct, LLC · 2008
- 2 generations backK080713 Reactive Dental Implant SystemImplant Direct, LLC · 2008
- 1 generation backK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · Recalled
- This deviceK250476 NizPlant Dental Implant SystemParagon Implant Mfg., LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | 2001 | 2 |
| −3 | K073161 | Replus Dental Implants (HA) | Implant Direct, LLC | 2008 | — |
| −2 | K080713 | Reactive Dental Implant System | Implant Direct, LLC | 2008 | — |
| −1 | K090234 | Spectra System Dental Implants 2008 | Implant Direct, LLC | 2009 | 11 |
| 0 (this device) | K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K090234 | Spectra System Dental Implants 2008Summary page 5…DZE (Primary) NHA (Secondary) Legally Marketed Predicate Device(s): Primary Predicate Device (DZE, NHA – K090234 (Spectra-System Dental Implants 2008), Implants, Abutments) Implant Direct LLC Primary Reference Devi… | 2009 |
| † | K202344 | TiUltra Implants and Xeal Abutments | 2020 |
| † | K232418 | Single Platform SP1 Implant System | 2023 |
| † | K222457 | Provata Implant System | 2023 |
| † | K223814 | Genesis ACTIVE Implant System | 2023 |
| † | K023113 | Replace Tiunite Endosseous Implant | 2002 |
| † | K080633 | Screwindirect Dental Implants | 2008 |
| † | K251938 | GEN5 and GEN5+ Dental Implant System | 2025 |
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 35 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 19 ancestors have a recall of any class.
- 7 other devices also cite its predicate K090234.
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?
NizPlant Implants are a one-piece implant or two-piece assembly for single-stage surgical procedures intended for surgical implantation in edentulous or partially edentulous mandibles or maxilla for attachment of complete denture prostheses, or for fixed or removable bridgework for multi-unit tooth replacement. NizPlant Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.…
Read the full statement (144 words)
NizPlant Implants are a one-piece implant or two-piece assembly for single-stage surgical procedures intended for surgical implantation in edentulous or partially edentulous mandibles or maxilla for attachment of complete denture prostheses, or for fixed or removable bridgework for multi-unit tooth replacement.
NizPlant Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.
Short (<9mml) Implants: Indicated for multiple-unit restorations of partially or fully edentulous mandibles and maxillae where vertical bone volume is limited.
The NizPlant Implants have a 2.SmmD internal hex within its most coronal portion for the insertion tool placement used in the full seating of the NizPlant Implant in the osteotomy. Implant placement, which is designed to receive multiple abutment variations, expands its restorative options allowing for the implant to be used for:
• Support of attachment-retained overdentures
• Support of screw-retained prostheses
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250476: NizPlant Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250476
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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