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 Comércia DE Materiais Dentários S.A. · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 27, 2025 as substantially equivalent to K233857 (JJGC Indústria e Comércio de Materiais Dentários S.A., 2024) after an 88-day review. Its family tree reaches back 12 generations to 1990. 1 later device descends from it.
- Decided
- May 27, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 54 ancestors in all, the oldest K894844 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK193234 NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- 2 generations backK203309 NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2021
- 1 generation backK233857 Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024
- This deviceK250614 Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2025
- Descendant · cites it directly · 0 of its ownK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 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 backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 5 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 4 generations backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- 3 generations backK193234 NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- 2 generations backK203309 NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2021
- 1 generation backK233857 Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024
- This deviceK250614 Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2025
Most influential descendants
Showing 1 of 1 · See all- K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026 · cites it directly0descendants
View 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 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −5 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| −4 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| −3 | K193234 | NUVO IF Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020 | — |
| −2 | K203309 | NUVO CF Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2021 | — |
| −1 | K233857 | Neodent Implant System – Custom Abutments | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024 | — |
| 0 (this device) | K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K233857 | Neodent Implant System – Custom AbutmentsSummary page 6…Neodent Implant System K250614 Predicate Device(s) Primary Predicate: • K233857 – Neodent Implant System – Custom Abutments Reference Devices: • K163194 – Neodent Implant System – GM Line •… | 2024 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K182620 | MRI Compatibility for Existing Neodent Implant System | 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 |
|---|---|---|---|
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | 2026 | 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 35 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 54 ancestors have a recall of any class.
- Of its descendants, K260460 (Institut Straumann AG, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Custom Abutment AS Ti: 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…
Read the full statement (165 words)
Custom Abutment AS Ti:
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.
ASC Screw:
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 procedures, for single or 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/K250614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250614: 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/K250614
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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