# K231566: ICX-Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Medentis Medical GmbH
- Decided: Sep 5, 2024 after 463 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: 20 generations back to K960026 (1996). 429 ancestors in all.
No later device cites it as a predicate yet.
0 of 430 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130222: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 5.
- K133510: Neodent Implant System, Jj Industria E Comercio DE Materiais Dentarios SA (2014) Summary page 5.
- K163194: Neodent Implant System - GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2017) Summary page 5.
- K222288: DESS Dental Smart Solutions, Terrats Medical SL (2022) Summary page 5.
- K193096: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2020) Summary page 5.
- K213063: TLX SRAs and TLX Gold Abutments, Institut Straumann AG (2022) Summary page 5.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 6.
- K140440: Noris Medical Dental Implants System, Noris Medical, Ltd. (2014) Summary page 6.
- K193046: Straumann® Retentive System – Novaloc TiN Abutments, Institut Straumann AG (2020) Summary page 6.
- K153779: Abutment for Bridges, Altatec GmbH (2016) Summary page 6.
- K203252: Multi-unit Abutments for CONELOG, BioHorizons Implant Systems, Inc. (2021) Summary page 6.
- K191123: Multi-unit Abutments, Medentika GmbH (2020) Summary page 6.
- K170131: TAV Medical Dental Implants System, Tav Medical, Ltd. (2018) Summary page 6.
- K233208: NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium, Nobel Biocare AB (2024). Cleared while this submission was under review Summary page 6.
- K212108: Dynamic TiBase, Talladium España, SL (2021) Summary page 6.

## Indications for use
ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only. ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla or mandible of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.

Source page: https://510kreport.com/device/K231566
Methodology: https://510kreport.com/methodology