# K070568: Dio Protem Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Department Dsi, Inc.
- Decided: May 25, 2007 after 86 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: 1 generation back to K051018 (2005). 1 ancestor in all.
8 later devices descend from it; 1 cites 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)
- K051018: Intermezzo Implant Systems, Megagen Co., Ltd. (2005) Summary page 3.

## Most influential descendants
- K080126: Dio Protem Implant System (2008), 7 descendants of its own
- 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

## Indications for use
The DIO Protem 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/K070568
Methodology: https://510kreport.com/methodology