# K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: May 7, 2026 after 85 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K894595 (1990). 223 ancestors in all.
No later device cites it as a predicate yet.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250614: Neodent Implant System - Custom Abutments, Jjgc Indústria E Comércia DE Materiais Dentários S.A. (2025) Summary page 8.
- K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments, Medentika GmbH (2024) Summary page 8.

## Indications for use
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.

Source page: https://510kreport.com/device/K260460
Methodology: https://510kreport.com/methodology