# K170608: UF (II) Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: Mar 30, 2018 after 394 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: 3 generations back to K041368 (2004). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122519: Dio UF Hsa Internal Sub-Merged Implant System, Dio Corporation (2013) Summary page 4.

## Most influential descendants
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K260006: INOSS System (2026), 0 descendants of its own
- K202832: Implacil Implant System (2021), 0 descendants of its own
- K192839: DSP Implant System (2021), 0 descendants of its own

## Indications for use
The UF(II) Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The UF(II) Implant System(Ø3.8 ~ Ø5.5) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.

Source page: https://510kreport.com/device/K170608
Methodology: https://510kreport.com/methodology