# K172100: URIS OMNI System

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: May 4, 2018 after 297 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: 14 generations back to K894595 (1990). 130 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121995: TS Fixture System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K120503: Cmi Implant IS II Active, Neobiotech Co., Ltd. (2012) Summary page 4.
- K081748: Oneplant Dental Implant System, Warantec Co., Ltd. (2009) Summary page 4.
- K153521: IH Implant System, Sewonmedix, Inc. (2016) Summary page 4.
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 4.
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 4.
- K153015: Transfer & Angled Abutment, Osstem Implant Co., Ltd. (2016) Summary page 4.
- K093027: Straumann RC Temporary Abutments, Straumann USA (2010) Summary page 4.

## Most influential descendants
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K231411: INNO SLA Submerged Hybrid Ti-Base System (2023), 1 descendant of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own
- K243255: URIS Long Implant & Abutments (2025), 0 descendants of its own

## Indications for use
URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Source page: https://510kreport.com/device/K172100
Methodology: https://510kreport.com/methodology