# K220251: Neodent Implant System - GM Narrow Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Sep 6, 2022 after 218 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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 K960026 (1996). 119 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123022: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2013) Summary page 4.
- K203309: NUVO CF Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A. (2021) Summary page 5.

## Most influential descendants
- K230104: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (2023), 0 descendants of its own

## Indications for use
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. The Implant Narrow GM is indicated to replace upper lateral incisors, lower incisors or for retaining overdenture prostheses. 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. Prosthetic component to be installed in the Narrow GM Implant, providing support for prosthetic structures. Indicated for temporary restorations with unitary structures, screwed, on implants installed in the maxilla or mandible. Temporary Abutments Narrow GM have a maximum duration of usage of 180 days. Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations as copings and crowns. It is indicated for cemented or screw mounted single-cemented applications on implants installed on the maxilla or mandible. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Source page: https://510kreport.com/device/K220251
Methodology: https://510kreport.com/methodology