# K955428: 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Feb 8, 1996 after 72 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.
324 later devices descend from it; 5 cite it directly.
0 of 325 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
- K030614: 3I Dental Implants (2003), 319 descendants of its own
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own
- K051189: Prevail Dental Implants (2005), 317 descendants of its own
- K051461: 3I Osseotite Dental Implants (2005), 312 descendants of its own
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite (2007), 211 descendants of its own

Source page: https://510kreport.com/device/K955428
Methodology: https://510kreport.com/methodology