# K092507: ZIT-Z

- Pathway: 510(k) (Traditional)
- Applicant: Ziterion
- Decided: May 11, 2010 after 267 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: 2 generations back to K022562 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061971: Zirconia Implant, Nobel Biocare AB (2007) Summary page 1.
- K062542: Z-LOOK3 Dental Implant System, Model Z3-XXX, Z-Systems AG (2007) Summary page 1.

## Indications for use
Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and, chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading. The 3.5mim implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upperjaw.

Source page: https://510kreport.com/device/K092507
Methodology: https://510kreport.com/methodology