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 Indústria e Comércio de Materiais Dentários S.A. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 13, 2023 as substantially equivalent to K201491 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2020) and 5 other predicates after a 176-day review. Its family tree reaches back 13 generations to 1990. 1 later device descends from it.
- Decided
- Dec 13, 2023
- Review
- 176 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K894595 (1990). 103 ancestors in all, the oldest K894844 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 2 generations backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- 1 generation backK202282 Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2021
- This deviceK231803 Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2023
- Descendant · cites it directly · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 10 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 9 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 7 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 6 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 5 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 4 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 3 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 2 generations backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- 1 generation backK202282 Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2021
- This deviceK231803 Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232383iPhysio® SystemEuroteknika · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −10 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −9 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −7 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −6 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −5 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −4 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −3 | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | Straumann USA | 2013 | — |
| −2 | K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017 | 6 |
| −1 | K202282 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2021 | — |
| 0 (this device) | K231803 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2023 | — |
| +1 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (6)
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 6…Zirconia Implant System 510(k) Summary K231803 Predicate Device and Reference Devices Primary Predicate: • K201491 - Neodent Implant System - Zirconia Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) Reference D… | 2020 |
| * | K210336 | Neodent Implant System - Zirconia Implant SystemSummary page 6…• K201491 - Neodent Implant System - Zirconia Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) Reference Devices: • K210336 – Neodent Implant System – Zirconia Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) • K… | 2021 |
| * | K202282 | Neodent Implant System - Zirconia Implant SystemSummary page 6…) Reference Devices: • K210336 – Neodent Implant System – Zirconia Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) • K202282 – Neodent Implant System – Zirconia Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) • K… | 2021 |
| * | K163194 | Neodent Implant System - GM LineSummary page 6…teriais Dentários S.A) • K202282 – Neodent Implant System – Zirconia Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) • K163194 – Neodent Implant System – GM Line (JJGC Indústria e Comércio de Materiais Dentários S.A) • K180477 - Strauma… | 2017 |
| * | K180477 | Straumann PURE Ceramic Implant SystemSummary page 6…Comércio de Materiais Dentários S.A) • K163194 – Neodent Implant System – GM Line (JJGC Indústria e Comércio de Materiais Dentários S.A) • K180477 - Straumann PURE Ceramic Implant System (Straumann USA, LLC) • K182620 – MRI Compatibility For Existing Neodent Implant… | 2019 |
| * | K182620 | MRI Compatibility for Existing Neodent Implant SystemSummary page 6…em – GM Line (JJGC Indústria e Comércio de Materiais Dentários S.A) • K180477 - Straumann PURE Ceramic Implant System (Straumann USA, LLC) • K182620 – MRI Compatibility For Existing Neodent Implant System Device Description The Zirconia Abutments subject of this submission a… | 2019 |
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 |
|---|---|---|---|
| K232383 | iPhysio® System | 2025 | 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 33 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 103 ancestors have a recall of any class.
- Of its descendants, K232383 (Euroteknika, 2025) has gone furthest, with 0 descendants of its own.
- 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?
Indications for Use for Zirconia Healing Abutment: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological…
Read the full statement (260 words)
Indications for Use for Zirconia Healing Abutment:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.
Healing,
Indications for Use for Zirconia Base:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made 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 for CR Abutment for Zirconia Implant System:
The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.
Indications for Use for PEEK CR Abutment for Zirconia Implant System:
The PEEK CR Abutment is indicated to be used on Neodent Implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231803: 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/K231803
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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