510(k) · Cleared
ClearedNeodent Implant System - Zirconia Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jjgc Industria E Comercio DE Materiais Dentarios S.A. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 14, 2023 as substantially equivalent to K201491 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2020) after a 368-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Jul 14, 2023
- Review
- 368 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894595 (1990). 52 ancestors in all, the oldest K894844 (1990). 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 backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 2 generations backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- 1 generation backK201491 Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- This deviceK222026 Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2023
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 backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 7 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 4 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 3 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 2 generations backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- 1 generation backK201491 Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- This deviceK222026 Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2023
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 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −7 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −4 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −3 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| −2 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| −1 | K201491 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020 | — |
| 0 (this device) | K222026 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K201491 | Neodent Implant System - Zirconia Implant SystemSummary page 4…Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K201491 – Neodent Implant System – Zirconia Implant System, JJGC Indústria e Comércio de Materiais… | 2020 |
| † | K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase… | 2015 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K223638 | Neodent Implant System - Helix Short Implant System | 2023 |
| † | K120053 | Ips E.Max Press - Abutment Solutions | 2012 |
| † | K130436 | Multilink Hybrid Abutment Cement | 2013 |
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 33 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 52 ancestors have a recall of any class.
- 3 other devices also cite its predicate K201491.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222026: Neodent Implant System - Zirconia 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/K222026
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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