# K080129: Secure Implant System (2.5/3.0MM)

- Pathway: 510(k) (Traditional)
- Applicant: Dio Department Dsi, Inc.
- Decided: May 30, 2008 after 134 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053354: Intermezzo Plus Fixture, Megagen Co., Ltd. (2006) Summary page 1.
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 1.

## Indications for use
Secure Implant System(2.5/3.0mm) is designed for use in dental implant surgery and is intended for use in a manner in which the implants integrate with the bone(osseointegration). It is intended to provide immediate transitional splinting stability or intrabony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients

Source page: https://510kreport.com/device/K080129
Methodology: https://510kreport.com/methodology