# K193404: UF (II) Bar holder abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: May 18, 2020 after 164 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: 13 generations back to K894595 (1990). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130408: Era Micro 23  Female Abutment, Era Micro 30 Female Abutment, Sterngold Dental, LLC (2013) Summary page 4.

## Indications for use
The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

Source page: https://510kreport.com/device/K193404
Methodology: https://510kreport.com/methodology