# K221488: Z7 Zirconia Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Z7, LLC
- Decided: Jun 26, 2023 after 399 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: 13 generations back to K944964 (1995). 95 ancestors in all.
No later device cites it as a predicate yet.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192053: W Zirconia Implants, Tav Medical, Ltd. (2019) Summary page 4.

## Indications for use
The Z7 Zirconia Implant System is intended for surgical placement in the patient’s upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.

Source page: https://510kreport.com/device/K221488
Methodology: https://510kreport.com/methodology