# K080126: Dio Protem Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Department Dsi, Inc.
- Decided: Apr 11, 2008 after 85 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 K051018 (2005). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070568: Dio Protem Implant System, Dio Department Dsi, Inc. (2007) Summary page 3.

## Most influential descendants
- K112540: S-Mini Implant System (2012), 5 descendants of its own
- K133050: One Plus Implant System (2014), 1 descendant of its own
- K241127: INNO SLA Mini Plus® Implant System (2024), 0 descendants of its own
- K181178: S-mini active Fixture (2018), 0 descendants of its own
- K170394: Kisses Mini (2017), 0 descendants of its own

## Indications for use
The DIO Protern Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Source page: https://510kreport.com/device/K080126
Methodology: https://510kreport.com/methodology