# K231915: Zfx Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Zfx GmbH - A Company of Zimvie
- Decided: Mar 1, 2024 after 246 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: 20 generations back to K960026 (1996). 325 ancestors in all.
No later device cites it as a predicate yet.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222288: DESS Dental Smart Solutions, Terrats Medical SL (2022) Summary page 5.

## Indications for use
The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture. Table 1 Compatible Implant Systems Compatible Implant Platform Ø (mm) Certain (Tapered and Parallel Walled), T3, T3 Pro: 3.4, 4.1, 5.0, 6.0 Tapered Screw-Vent, Trabecular Metal: 3.5, 4.5, 5.7 TSX: 2.9, 3.5, 4.5 Eztetic: 2.9 The Zfx TiBase abutments for the Ø3.25 mm Certain implant bodies, and Ø3.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

Source page: https://510kreport.com/device/K231915
Methodology: https://510kreport.com/methodology