# K190958: Neodent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Nov 9, 2019 after 211 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: 10 generations back to K925765 (1993). 72 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160119: NobelSpeedy Groovy, Nobel Biocare AB (2016) Summary page 4.

## Most influential descendants
- K212785: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments (2022), 3 descendants of its own
- K252168: Straumann® BLC Implants - Indication Widening (2026), 0 descendants of its own
- K252090: Pterygoid Indication for GM Helix Implants (2025), 0 descendants of its own
- K241462: LONGY Implant and LONGY-N Implant (2025), 0 descendants of its own
- K232726: External Hex Implant System (2024), 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 Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

Source page: https://510kreport.com/device/K190958
Methodology: https://510kreport.com/methodology