# K964739: Steri-Oss Tiodized Screw

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Mar 31, 1997 after 125 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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’ 1mm and 10mm Coping Screws: named in the summary without a submission number

## Most influential descendants
- K992538: Amorphous Diamond Coated Screw (1999), 1 descendant of its own
- K161177: Axiom PX (2017), 0 descendants of its own

## Indications for use
The intended use for Steri-Oss’ tiodized® screws is the screw retained attachment of prosthetic components to one another and to dental implants.

Source page: https://510kreport.com/device/K964739
Methodology: https://510kreport.com/methodology