# K160536: Chaorum Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Medimecca Co., Ltd.
- Decided: Jan 5, 2017 after 314 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: 10 generations back to K894595 (1990). 20 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131682: UD Implant System, Medimecca Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K231932: TDS (Techwin Dental System) (2024), 0 descendants of its own
- K211978: Jplant (2022), 0 descendants of its own
- K202039: Honorst Implant System (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K160536
Methodology: https://510kreport.com/methodology