# K121709: ZFX Dental Cad System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Oct 19, 2012 after 130 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) etkonTM -visual: named in the summary without a submission number
- (no number) etkonTM esi: named in the summary without a submission number
- (no number) Straumann CARES: named in the summary without a submission number

## Indications for use
The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.

Source page: https://510kreport.com/device/K121709
Methodology: https://510kreport.com/methodology