# K200817: URIS OMNI Narrow System & Prosthetic

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Oct 7, 2020 after 191 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: 17 generations back to K960026 (1996). 431 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 438 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172100: URIS OMNI System, Truabutment, Inc. (2018) Summary page 4.
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 4.
- K140507: Hiossen Prosthetic System, Osstem Implant Co., Ltd. (2014) Summary page 4.
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 4.
- K123755: Multi Angled Abutment, Osstem Implant Co., Ltd. (2013) Summary page 4.
- K120951: Smartbuilder System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K123988: Anyonetm Internal Implant System, Megagen Implant Co., Ltd. (2013) Summary page 4.
- K160670: ET US SS Prosthetic system, Osstem Implant Co., Ltd. (2017) Summary page 4.
- K081748: Oneplant Dental Implant System, Warantec Co., Ltd. (2009) Summary page 4.
- K183106: TruAbutment DS, Truabutment, Inc. (2020) Summary page 4.
- K183518: Preat Abutments, Preat Corporation (2019) Summary page 4.

## Most influential descendants
- 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
- K230438: URIS Smart Path Implant System & Prosthetic (2023), 0 descendants of its own

## Indications for use
URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors, 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. The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures. All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Source page: https://510kreport.com/device/K200817
Methodology: https://510kreport.com/methodology