# K100724: Osseotite II Model Xifossxxx

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, Inc.
- Decided: Apr 1, 2011 after 382 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K925765 (1993). 66 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 1.
- K062636: Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental Implants, Implant Innovations, Inc. (2007) Summary page 1.
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite, Implant Innovations, Inc. (2007) Summary page 1.

## Most influential descendants
- K122300: T3 Dental Implant (2013), 22 descendants of its own
- K111216: Osseotite 2 Dental Implants (2011), 21 descendants of its own
- K133049: 3I T3(R) External Hex Dental Implants (2014), 19 descendants of its own
- K163634: External Hex Implants (2017), 13 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own

## Recalls of this device
- Nov 7, 2014 · Class II · Z-1410-2015: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
- Jun 10, 2013 · Class II · Z-2207-2013: One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
- Sep 28, 2012 · Class II · Z-0297-2013: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too sha
- Sep 28, 2012 · Class II · Z-0298-2013: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too sha
- Nov 18, 2010 · Not classified · Z-0171-2012: The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant.

## Indications for use
BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.

Source page: https://510kreport.com/device/K100724
Methodology: https://510kreport.com/methodology