# K061629: Certain Prevail Dental Implant

- Pathway: 510(k) (Special)
- Applicant: Implant Innovations, Inc.
- Decided: Feb 23, 2007 after 256 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
Longest line of descent: 7 generations back to K925765 (1993). 60 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K051189: Prevail Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.

## Most influential descendants
- K063106: Revois Implant System (2007), 2 descendants of its own
- K113539: Revois Pro Implant Stsyem (2013), 0 descendants of its own
- K113042: Revois Implant System (2013), 0 descendants of its own
- K082749: Omni-Tight (2008), 0 descendants of its own

## Indications for use
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures. In addition, when a minimum of 4 implants, > 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

Source page: https://510kreport.com/device/K061629
Methodology: https://510kreport.com/methodology