# K233857: Neodent Implant System – Custom Abutments

- Pathway: 510(k) (Traditional)
- Applicant: JJGC Indústria e Comércio de Materiais Dentários S.A.
- Decided: May 2, 2024 after 149 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: 11 generations back to K894595 (1990). 53 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203309: NUVO CF Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A. (2021) Summary page 6.

## Most influential descendants
- K250614: Neodent Implant System - Custom Abutments (2025), 1 descendant of its own
- K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K233857
Methodology: https://510kreport.com/methodology