510(k) · Cleared
Recalled · Class II · 2026Neodent Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jjgc Indústria E Comércia DE Materiais Dentários S.A. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 4, 2024 as substantially equivalent to K163194 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2017) after an 89-day review. Its family tree reaches back 12 generations to 1990. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 4, 2024
- Review
- 89 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 89 ancestors in all, the oldest K894844 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 1 generation backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- This deviceK242686 Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2024
- Descendant · cites it directly · 0 of its ownK261147 Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026
- Descendant · cites it directly · 0 of its ownK252727 Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 9 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 6 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 5 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 4 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 1 generation backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- This deviceK242686 Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −9 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −6 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −5 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −4 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −3 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −2 | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | Straumann USA | 2013 | — |
| −1 | K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017 | 6 |
| 0 (this device) | K242686 | Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2024 | — |
| +1 | K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026 | — |
| +1 | K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026 | — |
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 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K163194 | Neodent Implant System - GM LineSummary page 6…Neodent Implant System 510(k) Summary Predicate Device(s) NeoConvert Solution: Primary Predicate: K163194 Neodent Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) Reference Devices: K101945 Neode… | 2017 |
| † | K101945 | Neodent Implant System | 2011 |
| † | K193234 | NUVO IF Implant System | 2020 |
| † | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K192229 | Neodent Implant System- GM Titanium Base for Bridge | 2019 |
| † | K202452 | NobelProcera Zirconia Implant Bridge | 2020 |
| † | K203309 | NUVO CF Implant System | 2021 |
| † | K203542 | Neodent Implant System - Mini Abutment 60° | 2021 |
| † | K220251 | Neodent Implant System - GM Narrow Implant System | 2022 |
| † | K223638 | Neodent Implant System - Helix Short Implant System | 2023 |
| † | K173902 | Neodent Implant System – GM Line | 2018 |
| † | K182620 | MRI Compatibility for Existing Neodent Implant System | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2026 | Class II | Z-1994-2026 | Under Investigation by firm | Includes an incorrect screw seat interface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 89 ancestors have a recall of any class.
- Of its descendants, K261147 (JJGC Indústria e Comércio de Materiais Dentários S.A., 2026) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K163194.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 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. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent Implant System is…
Read the full statement (227 words)
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. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
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. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.
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. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242686 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242686: Neodent Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242686
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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