# K911592: Steri-Oss Titanium Plama Spray Cylindrical Implant

- Pathway: 510(k) (Traditional)
- Applicant: Steri-Oss, Inc.
- Decided: Jul 22, 1993 after 835 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.
633 later devices descend from it; 2 cite it directly.
0 of 634 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K973423: Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental Implant (1997), 631 descendants of its own
- K020646: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 (2002), 630 descendants of its own
- K022424: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 (2002), 625 descendants of its own
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own
- K050705: Tiunite Implants (2005), 532 descendants of its own

Source page: https://510kreport.com/device/K911592
Methodology: https://510kreport.com/methodology