# K231803: Neodent Implant System - Zirconia Implant System

- Pathway: 510(k) (Traditional)
- Applicant: JJGC Indústria e Comércio de Materiais Dentários S.A.
- Decided: Dec 13, 2023 after 176 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: 13 generations back to K894595 (1990). 103 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 105 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 6.
- K210336: Neodent Implant System - Zirconia Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2021) Summary page 6.
- K202282: Neodent Implant System - Zirconia Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2021) Summary page 6.
- K163194: Neodent Implant System - GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2017) Summary page 6.
- K180477: Straumann PURE Ceramic Implant System, Institut Straumann AG (2019) Summary page 6.
- K182620: MRI Compatibility for Existing Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2019) Summary page 6.

## Most influential descendants
- K232383: iPhysio® System (2025), 0 descendants of its own

## Indications for use
Indications for Use for Zirconia Healing Abutment: 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 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. Healing, Indications for Use for Zirconia Base: The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made 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. Indications for Use for CR Abutment for Zirconia Implant System: The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible. Indications for Use for PEEK CR Abutment for Zirconia Implant System: The PEEK CR Abutment is indicated to be used on Neodent Implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

Source page: https://510kreport.com/device/K231803
Methodology: https://510kreport.com/methodology