# K973423: Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)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
Longest line of descent: 1 generation back to K911592 (1993). 1 ancestor in all.
631 later devices descend from it; 1 cites it directly.
0 of 633 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911592: Steri-Oss Titanium Plama Spray Cylindrical Implant, Steri-Oss, Inc. (1993) Summary page 1.
- (no number) Steri-Oss’ (Hydroxyapatite-coated) Replace Implants: named in the summary without a submission number

## Most influential descendants
- 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
- K050258: Groovy Implants (2005), 511 descendants of its own

## 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/K973423
Methodology: https://510kreport.com/methodology