# K190048: UF (II) Anatomic abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: Sep 30, 2019 after 263 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: 6 generations back to K894844 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 4.

## Indications for use
The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.

Source page: https://510kreport.com/device/K190048
Methodology: https://510kreport.com/methodology