# K132585: Zibone Ceramic Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Coho Technology Co., Ltd.
- Decided: Jun 4, 2014 after 292 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: 1 generation back to K062542 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
Zibone one-piece ceramic dental implants are indicated for implantation into the upper or lower jaw to replace missing teeth. They are indicated for (delayed or immediate) loading once primary stability has been achieved.

Source page: https://510kreport.com/device/K132585
Methodology: https://510kreport.com/methodology