# K122519: Dio UF Hsa Internal Sub-Merged Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: May 21, 2013 after 277 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: 2 generations back to K041368 (2004). 2 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060501: Implantium II, Dentium Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K170608: UF (II) Implant System (2018), 4 descendants of its own
- K221866: S-Plant Dental Implant System (2024), 2 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K182194: UV Active Implant System (2018), 1 descendant of its own
- K260006: INOSS System (2026), 0 descendants of its own

## Indications for use
The DIO UP HSA Internal Sub-Merged 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 smaller (03.8 - 05.5) 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 larger (06.0 -- 07.0) 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/K122519
Methodology: https://510kreport.com/methodology