# K072363: Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, Inc.
- Decided: Jan 31, 2008 after 161 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: 8 generations back to K925765 (1993). 61 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051461: 3I Osseotite Dental Implants, Implant Innovations, Inc. (2005) Summary page 1.

## Most influential descendants
- K170398: S.I.N. Dental Implant System (2017), 17 descendants of its own
- K112532: ET II Bio-SA Fixture System (2012), 10 descendants of its own
- K151626: ET III Bio-SA Fixture System (2016), 9 descendants of its own
- K203725: S.I.N. Dental Implant System (2021), 8 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own

## Indications for use
BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. BIOMET 3i NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Source page: https://510kreport.com/device/K072363
Methodology: https://510kreport.com/methodology