# K954347: 3I Standard Threaded Implant

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Apr 1, 1996 after 196 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.
1,047 later devices descend from it; 3 cite it directly.
0 of 1,048 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K984104: Iti Dental Implant System (1999), 1,043 descendants of its own
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) (2000), 942 descendants of its own
- K992937: Dental Implant (2000), 735 descendants of its own
- K023113: Replace Tiunite Endosseous Implant (2002), 689 descendants of its own
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own

## Indications for use
The 3i Implant System is designed for use in dental implant surgery. The 3i Implant System includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants. These implants are surgically inserted into the upper and/or lower jawbones. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium or titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.

Source page: https://510kreport.com/device/K954347
Methodology: https://510kreport.com/methodology