# K242686: Neodent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Indústria E Comércia DE Materiais Dentários S.A.
- Decided: Dec 4, 2024 after 89 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894595 (1990). 89 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163194: Neodent Implant System - GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2017) Summary page 6.

## Most influential descendants
- K261147: Neodent Implant System - NeoConvert Fit (2026), 0 descendants of its own
- K252727: Neodent InLab Validated Workflow (2026), 0 descendants of its own

## Recalls of this device
- Mar 27, 2026 · Class II · Z-1994-2026: Includes an incorrect screw seat interface.

## 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. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. 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. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center. 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. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for 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/K242686
Methodology: https://510kreport.com/methodology