# K260463: ZEROS Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Zeros Co., Ltd.
- Decided: Aug 19, 2026 after 188 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: 14 generations back to K894595 (1990). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232268: STERI-OSS Implant System, Zeros Co., Ltd. (2024) Summary page 5.

## Indications for use
ZEROS Dental Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. ZEROS Dental Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K260463
Methodology: https://510kreport.com/methodology