# K230438: URIS Smart Path Implant System & Prosthetic

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Dec 29, 2023 after 311 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: 18 generations back to K960026 (1996). 432 ancestors in all.
No later device cites it as a predicate yet.
0 of 433 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 5.
- K200817: URIS OMNI Narrow System & Prosthetic, Truabutment, Inc. (2020) Summary page 5.

## Indications for use
URIS Smart Path Implant System & Prosthetic 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. All digitally designed abutments and/or coping for use with URIS Smart Path Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Source page: https://510kreport.com/device/K230438
Methodology: https://510kreport.com/methodology