510(k) · Cleared
ClearedJDEvolution Plus L and JDEvolution Plus LE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jdentalcare Srl · DZE Implant, Endosseous, Root-Form
Cleared on Sep 25, 2025 as substantially equivalent to K160119 (Nobel Biocare AB, 2016) after a 164-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Sep 25, 2025
- Review
- 164 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K925765 (1993). 72 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations between
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 1 generation backK160119 NobelSpeedy GroovyNobel Biocare AB · 2016
- This deviceK251148 JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl · 2025
Show all 10 generations
- Root · 10 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 9 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 8 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 7 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 6 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 5 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 4 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
- 1 generation backK160119 NobelSpeedy GroovyNobel Biocare AB · 2016
- This deviceK251148 JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −9 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −8 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −7 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −6 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −5 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −4 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| −1 | K160119 | NobelSpeedy Groovy | Nobel Biocare AB | 2016 | — |
| 0 (this device) | K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K160119 | NobelSpeedy GroovySummary page 6…code Nobel Biocare AB NobelSpeedy® Groovy K160119 DZE This predicate device has not been subject to a design-related recall. Reference device that has been considered i… | 2016 |
| † | K143142 | JDENTALCARE Implant System | 2015 |
| † | K182081 | JDentalCare Implant System JDIcon | 2020 |
| † | K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | 2024 |
| † | K050406 | Nobelspeedy Implants | 2005 |
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 32 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 72 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160119.
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?
JDEvolution Plus L and JDEvolution Plus LE implant system is intended for surgical placement in the upper jaw. JDEvolution Plus L and JDEvolution Plus LE implant system provides a means for prosthetic attachment in partially or fully edentulous spans with multiple teeth utilizing delayed, or immediate loading, or as a terminal or intermediary abutment for fixed ore removable bridgework or to retain overdentures. JDEvolution Plus L and JDEvolution Plus LE…
Read the full statement (131 words)
JDEvolution Plus L and JDEvolution Plus LE implant system is intended for surgical placement in the upper jaw.
JDEvolution Plus L and JDEvolution Plus LE implant system provides a means for prosthetic attachment in partially or fully edentulous spans with multiple teeth utilizing delayed, or immediate loading, or as a terminal or intermediary abutment for fixed ore removable bridgework or to retain overdentures. JDEvolution Plus L and JDEvolution Plus LE is intended for immediate function multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
JDEvolution Plus L and JDEvolution Plus LE implants with lengths of 18, 20, 22, 24, 26 mm are only indicated for multiple unit restorations in splinted applications with at least two implants when placed in the maxilla.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251148: JDEvolution Plus L and JDEvolution Plus LE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251148
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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