# K935544: 3I Standard Threaded/Self-Tapping Threaded Implants Modification

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations International, Inc.
- Decided: Mar 13, 1995 after 486 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.
601 later devices descend from it; 13 cite it directly.
0 of 602 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
- K014235: Osseotite NT Dental Implants & Accessories (2002), 583 descendants of its own
- K013570: Osseotite Dental Implants (2001), 495 descendants of its own
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants (2002), 478 descendants of its own
- K022113: 3I Dental Implant Accessories (2002), 463 descendants of its own
- K062069: Atlantis Abutment for 3I Micromini Implant (2007), 361 descendants of its own

Source page: https://510kreport.com/device/K935544
Methodology: https://510kreport.com/methodology