# K080559: Dio SM Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dsi, Inc.
- Decided: Oct 9, 2008 after 224 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 K061797 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061797: SM Implant Systems, Dio Department Dsi, Inc. (2006) Summary page 1.

## Indications for use
The DIO SM Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple 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 immediate loading, Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

Source page: https://510kreport.com/device/K080559
Methodology: https://510kreport.com/methodology