# K141544: Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Oct 22, 2014 after 134 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894595 (1990). 122 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134045: Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant System, Zimmer Dental, Inc. (2014) Summary page 4.
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar, Implant Innovations, Inc. (2004) Summary page 4.
- K052648: Modification to 3I Patient-Specific Dental Abutments and Overdenture Bars, Implant Innovations, Inc. (2005) Summary page 4.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 4.

## Most influential descendants
- K143505: Zimmer Patient-Specific Abutment, Internal Hex, Titanium (2015), 8 descendants of its own
- K181037: DIO CAD/CAM Abutment (2018), 7 descendants of its own
- K160850: Nucleoss Tpure Implant System (2017), 2 descendants of its own
- K222913: s-Clean Link Abutment (2023), 1 descendant of its own
- K210362: s-Clean Pre-Milled Abutment (2021), 1 descendant of its own

## Indications for use
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.

Source page: https://510kreport.com/device/K141544
Methodology: https://510kreport.com/methodology