510(k) · Cleared
ClearedNeodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 7, 2026 as substantially equivalent to K250614 (Jjgc Indústria E Comércia DE Materiais Dentários S.A., 2025) and 1 other predicate after an 85-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- May 7, 2026
- Review
- 85 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K894595 (1990). 223 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK142167 Medentika Abutment SystemMedentika GmbH · 2015
- 1 generation backK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
- This deviceK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 10 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 9 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 8 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 7 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 6 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK142167 Medentika Abutment SystemMedentika GmbH · 2015
- 1 generation backK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
- This deviceK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −10 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −9 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −8 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −7 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −6 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −3 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −2 | K142167 | Medentika Abutment System | Medentika GmbH | 2015 | — |
| −1 | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM… | Medentika GmbH | 2024 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 10 | 0 |
| 1995 | 12 | 0 |
| 1996 | 15 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 14 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K250614 | Neodent Implant System - Custom AbutmentsSummary page 8…itional 510(k) Submission Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue K260460 510(k) Summary • K250614 – Neodent Implant System – Custom Abutments o Custom Abutments AS (angulated screw channel) for NGM and HS and… | 2025 |
| * | K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Summary page 8…• K253341 – Medentika Custom Abutments Angulated Screw Channel (AS) o Custom Abutments AS Series E, EV, F, H, I, K, L, N, OT, R, S and T • K223113 – Medentika Abutment System, Medentika CAD/CAM Abutments o Custom Abutments Series E, EV, F, and OT with a strai… | 2024 |
| † | K233857 | Neodent Implant System – Custom Abutments | 2024 |
| † | K162848 | Straumann CARES Golden Ti/TiN Abutments | 2017 |
| † | K253341 | Custom Abutments AS | 2025 |
| † | K150203 | Medentika CAD/CAM Abutments | 2015 |
| † | K242542 | Medentika CAD/CAM Abutments | 2025 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K223638 | Neodent Implant System - Helix Short Implant System | 2023 |
| † | K220251 | Neodent Implant System - GM Narrow Implant System | 2022 |
| † | K170838 | Medentika CAD/CAM TiBases | 2017 |
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 36 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 26 of the 223 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Gold Hue Custom Abutment 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. Gold Hue Custom Abutments are indicated for screw-retained single restorations or cemented-retained single or multiple…
Read the full statement (203 words)
The Gold Hue Custom Abutment 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. Gold Hue Custom Abutments are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Gold Hue Custom Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.
Medentika Custom Abutments Gold Hue are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Custom Abutments Gold Hue are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments Gold Hue are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment Gold Hue.
Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260460
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026