510(k) · Cleared
ClearedJDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
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 Aug 16, 2024 as substantially equivalent to K182081 (Jdentalcare Srl, 2020) after a 249-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Aug 16, 2024
- Review
- 249 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894595 (1990). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 2 generations backK143142 JDENTALCARE Implant SystemJdentalcare Srl · 2015
- 1 generation backK182081 JDentalCare Implant System JDIconJdentalcare Srl · 2020
- This deviceK233896 JDentalCare Dental Implant System: JDEvolution; JDEvolution plus…Jdentalcare Srl · 2024
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 2 generations backK143142 JDENTALCARE Implant SystemJdentalcare Srl · 2015
- 1 generation backK182081 JDentalCare Implant System JDIconJdentalcare Srl · 2020
- This deviceK233896 JDentalCare Dental Implant System: JDEvolution; JDEvolution plus…Jdentalcare Srl · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −2 | K143142 | JDENTALCARE Implant System | Jdentalcare Srl | 2015 | — |
| −1 | K182081 | JDentalCare Implant System JDIcon | Jdentalcare Srl | 2020 | — |
| 0 (this device) | K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon… | Jdentalcare Srl | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 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 |
|---|---|---|---|
| * | K182081 | JDentalCare Implant System JDIconSummary page 6…JDentalCare® Implant System DZE J DENTAL CARE S.r.l. K182081 JDIcon® NHA These predicate devices ha… | 2020 |
| † | K143142 | JDENTALCARE Implant System | 2015 |
| † | K153111 | TOUAREG CloseFit™ UNP 2.75mmD | 2016 |
| † | K202344 | TiUltra Implants and Xeal Abutments | 2020 |
| † | K160119 | NobelSpeedy Groovy | 2016 |
| † | K142260 | NobelActive | 2015 |
| † | K171142 | Healing Cap Multi-Unit Titanium | 2017 |
| † | K163349 | MIS V3 Conical Connection Dental Implant System | 2017 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 24 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
JDentalCare Dental Implant System, family names JDEvolution, JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible. JDentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed…
Read the full statement (226 words)
JDentalCare Dental Implant System, family names JDEvolution, JDEvolution Plus, JDIcon, JDIcon Plus, is intended to
replace missing masticatory functional units (teeth) within the maxilla or mandible.
JDentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for
prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing
delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain
overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible
and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth and/or multiple tooth
applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing
function. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary
stability is achieved and the functional load is appropriate.
Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that
utilize at least two implants.
JDentalCare implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and
mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in
extraction sites or implantation in partially healed or completely healed alveolar ridge situations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233896: JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233896
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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