# K972444: 3I Innovative Implants and Cover Screws

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Aug 26, 1997 after 57 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
335 later devices descend from it; 8 cite it directly.
0 of 336 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) 3i Endosseous Dental Implant Systems: named in the summary without a submission number
- (no number) ITI Straumann Dental Implant System: named in the summary without a submission number

## Most influential descendants
- K031475: Osseotite NT Certain Implants (2003), 330 descendants of its own
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants (2003), 320 descendants of its own
- 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

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2521-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2500-2016: Pouches may not have been sealed during packing.

## Indications for use
Indications for use of the 3i Endosseous Dental Implant Systems are not altered by this submission. An Endosseous Dental Implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient’s chewing function.

Source page: https://510kreport.com/device/K972444
Methodology: https://510kreport.com/methodology