# K242064: Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

- Pathway: 510(k) (Abbreviated)
- Applicant: Smart Denture Conversions, LLC
- Decided: Jan 17, 2025 after 186 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: 10 generations back to K894595 (1990). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 5.

## Most influential descendants
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

## 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/K242064
Methodology: https://510kreport.com/methodology