# K973402: Steri-Oss 3.25 MM Replace Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Nov 26, 1997 after 78 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 K911592 (1993). 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)
- K964220: Replace Titanium Implant System, Steri-Oss, Inc. (1997) Summary page 1.
- K911592: Steri-Oss Titanium Plama Spray Cylindrical Implant, Steri-Oss, Inc. (1993) Summary page 1.

## Indications for use
The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

Source page: https://510kreport.com/device/K973402
Methodology: https://510kreport.com/methodology