# K944158: Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Mar 29, 1995 after 215 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.
330 later devices descend from it; 1 cites it directly.
0 of 331 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963224: Steri-Oss Implants for Single Stage Placement (1996), 329 descendants of its own
- K041236: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 (2004), 328 descendants of its own
- K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 (2004), 327 descendants of its own
- K090069: Procera Implant Bridge Overdenture (2009), 313 descendants of its own
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own

Source page: https://510kreport.com/device/K944158
Methodology: https://510kreport.com/methodology