# K182194: UV Active Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: Dec 14, 2018 after 122 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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 5.

## Most influential descendants
- K222946: Oneday Mini Implant System (2023), 0 descendants of its own

## Indications for use
The UV Active 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 narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading. The Regular (Ø3.8 ~ Ø5.5) implants 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. The Wide (Ø6.0 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Source page: https://510kreport.com/device/K182194
Methodology: https://510kreport.com/methodology