# K150021: Z5m (t)

- Pathway: 510(k) (Traditional)
- Applicant: Z-Systems AG
- Decided: Jul 31, 2015 after 206 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K022562 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120793: Z-LOOK3 Evo SLM, Z-Systems AG (2012) Summary page 5.

## Indications for use
Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Source page: https://510kreport.com/device/K150021
Methodology: https://510kreport.com/methodology