# K963224: Steri-Oss Implants for Single Stage Placement

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Nov 14, 1996 after 90 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 K944158 (1995). 1 ancestor in all.
329 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)
- K944158: Steri-Oss Titanium Alloy Screw Series Implant for Single Stage Surgical Placement, Steri-Oss, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own

## Indications for use
Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.

Source page: https://510kreport.com/device/K963224
Methodology: https://510kreport.com/methodology