# K973433: Steri-Oss 3.25 MM Replace (Titanium Plasma Sprayed) Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Dec 5, 1997 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Steri-Oss Replace Implants: named in the summary without a submission number
- (no number) Steri-Oss 3.25 mm titanium plasma sprayed cylindrical implant: named in the summary without a submission number

## 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/K973433
Methodology: https://510kreport.com/methodology