# K222026: Neodent Implant System - Zirconia Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Jul 14, 2023 after 368 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: 10 generations back to K894595 (1990). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201491: Neodent Implant System - Zirconia Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2020) Summary page 4.

## Indications for use
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/K222026
Methodology: https://510kreport.com/methodology