# K161604: OSSTEM Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Oct 17, 2016 after 129 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
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K233194: TS Abutment System (2024), 2 descendants of its own
- K222778: Osstem Implant System (2023), 2 descendants of its own
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K242753: SD TL Implant System (2025), 1 descendant of its own

## Indications for use
The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Fixture System is intended to be used in the molar region. Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

Source page: https://510kreport.com/device/K161604
Methodology: https://510kreport.com/methodology