# K200386: Z5-BL

- Pathway: 510(k) (Traditional)
- Applicant: Z-Systems AG
- Decided: Oct 14, 2020 after 239 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: 12 generations back to K960026 (1996). 161 ancestors in all.
No later device cites it as a predicate yet.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190243: Z5-BL, Z-Systems AG (2020) Summary page 4.
- K132881: Z5C, Z-Systems AG (2014) Summary page 4.
- K131701: Z5MLB, Z5MLC, Z-Systems AG (2013) Summary page 4.
- K120793: Z-LOOK3 Evo SLM, Z-Systems AG (2012) Summary page 4.

## Indications for use
Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Source page: https://510kreport.com/device/K200386
Methodology: https://510kreport.com/methodology