# K201491: Neodent Implant System - Zirconia Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Dec 22, 2020 after 201 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: 9 generations back to K894595 (1990). 51 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 5.

## Most influential descendants
- K210336: Neodent Implant System - Zirconia Implant System (2021), 2 descendants of its own
- K231803: Neodent Implant System - Zirconia Implant System (2023), 1 descendant of its own
- K250271: Neodent Implant System - Zirconia Implant System (2025), 0 descendants of its own
- K232383: iPhysio® System (2025), 0 descendants of its own
- K222026: Neodent Implant System - Zirconia Implant System (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 singlestage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Source page: https://510kreport.com/device/K201491
Methodology: https://510kreport.com/methodology