# K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)

- Pathway: 510(k) (Abbreviated)
- Applicant: Smart Denture Conversions, LLC
- Decided: Jun 11, 2026 after 171 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: 18 generations back to K960026 (1996). 415 ancestors in all.
No later device cites it as a predicate yet.
0 of 416 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242064: Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™), Smart Denture Conversions, LLC (2025) Summary page 6.
- K240208: DESS Dental Smart Solutions, Terrats Medical SL (2024) Summary page 6.
- K232418: Single Platform SP1 Implant System, Southern Implants (Pty), Ltd. (2023) Summary page 6.
- K180465: Provata Implant System, Southern Implants (Pty), Ltd. (2018) Summary page 6.
- K213576: Tatum Surgical Dental Implant System, Suncoast Dental, Inc. Dba Tatum Surgical (2022) Summary page 6.

## Indications for use
The Omnibut is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K254145
Methodology: https://510kreport.com/methodology