# K143505: Zimmer Patient-Specific Abutment, Internal Hex, Titanium

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Jun 25, 2015 after 197 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: 12 generations back to K894595 (1990). 123 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071439: Zimmer Patient-Specific Abutment, Internal Hex, Titanium, Zimmer Dental, Inc. (2007) Summary page 4.
- K134045: Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant System, Zimmer Dental, Inc. (2014) Summary page 4.
- K141544: Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System, Zimmer Dental, Inc. (2014) Summary page 4.

## Most influential descendants
- K181037: DIO CAD/CAM Abutment (2018), 7 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
- K242703: LW Pre-milled Abutment (2024), 0 descendants of its own
- K232170: Ti Link Abutment (2024), 0 descendants of its own

## Indications for use
The Zimmer® Patient Specific Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.

Source page: https://510kreport.com/device/K143505
Methodology: https://510kreport.com/methodology