510(k) · Cleared
ClearedNeodent Implant System – Custom Abutments
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 May 2, 2024 as substantially equivalent to K203309 (JJGC Indústria e Comércio de Materiais Dentários S.A., 2021) after a 149-day review. Its family tree reaches back 11 generations to 1990. 2 later devices descend from it.
- Decided
- May 2, 2024
- Review
- 149 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K894595 (1990). 53 ancestors in all, the oldest K894844 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- 2 generations backK193234 NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- 1 generation backK203309 NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2021
- This deviceK233857 Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024
- Descendant · cites it directly · 1 of its ownK250614 Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2025
- Descendant · 2 generations on · 0 of its ownK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 8 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 5 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 4 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 3 generations backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- 2 generations backK193234 NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- 1 generation backK203309 NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2021
- This deviceK233857 Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio 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 |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −8 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −5 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −4 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| −3 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| −2 | K193234 | NUVO IF Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020 | — |
| −1 | K203309 | NUVO CF Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2021 | — |
| 0 (this device) | K233857 | Neodent Implant System – Custom Abutments | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024 | — |
| +1 | K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2025 | — |
| +2 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K203309 | NUVO CF Implant SystemSummary page 6…tom Abutments 510(k) Summary Predicate Device(s) Primary Predicate: • K203309 – Nuvo CF Implant System (JJGC Indústria e Comércio de Materiais Dentários S.A) Reference Devic… | 2021 |
| † | K150367 | Neodent Implant System | 2015 |
| † | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 |
| † | K182620 | MRI Compatibility for Existing Neodent Implant System | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250614 | Neodent Implant System - Custom Abutments | 2025 | 1 |
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 8 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 53 ancestors have a recall of any class.
- Of its descendants, K250614 (Jjgc Indústria E Comércia DE Materiais Dentários S.A., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K203309.
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 Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or…
Read the full statement (184 words)
The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233857: Neodent Implant System – Custom Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233857
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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