# K133551: Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Jul 18, 2014 after 241 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: 14 generations back to K894844 (1990). 182 ancestors in all.
No later device cites it as a predicate yet.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001) Summary page 1.
- K132219: Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN, Straumann (R) Variobase (TM) Abutment WN,, Straumann USA, LLC (2014). Cleared while this submission was under review Summary page 1.

## Indications for use
The Zimmer ZNx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer ZNx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.

Source page: https://510kreport.com/device/K133551
Methodology: https://510kreport.com/methodology