# K250614: Neodent Implant System - Custom Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Indústria E Comércia DE Materiais Dentários S.A.
- Decided: May 27, 2025 after 88 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: 12 generations back to K894595 (1990). 54 ancestors in all.
1 later device descends 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)
- K233857: Neodent Implant System – Custom Abutments, JJGC Indústria e Comércio de Materiais Dentários S.A. (2024) Summary page 6.

## Most influential descendants
- K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K250614
Methodology: https://510kreport.com/methodology