# K143528: Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: May 1, 2015 after 140 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: 1 generation back to K011028 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.

Source page: https://510kreport.com/device/K143528
Methodology: https://510kreport.com/methodology