# K960417: 3I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp. Healing Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Aug 1, 1996 after 185 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; 4 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 its predicate without a number.
- (no number) Non-Submerged Implant System: named in the summary without a submission number
- (no number) Immediate-Load Implant: named in the summary without a submission 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
A single-stage surgical process by which a 3i implant is placed into the bone and a 1 or 2 piece (EP) Temporary Healing Abutment is immediately attached to the implant, may be considered in those cases where the implant and healing abutment can be adequately protected from mastication forces throughout the healing period, by opposing dentition, denture or bridge that if required, may be modified to provide such protection.

Source page: https://510kreport.com/device/K960417
Methodology: https://510kreport.com/methodology