# K100100: Dio Steady External Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: Nov 10, 2010 after 302 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 K061797 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070569: SM Internal./External Implant System, Dio Department Dsi, Inc. (2007) Summary page 1.

## Indications for use
The DIO STEADY External Implant System is an endosseous dental imnpl ant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or mdltiple units' prosthetic appliance attachment to restore a patient's chewing function. 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 imimediate loading. Immediate loading is restricted. to the anterior mandible, based on four interforaminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endo~seous implants.

Source page: https://510kreport.com/device/K100100
Methodology: https://510kreport.com/methodology