# K160060: DMi Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dmi Innovative Medical Technology, Ltd.
- Decided: Oct 3, 2016 after 265 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The DMi Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function. The DMi Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading

Source page: https://510kreport.com/device/K160060
Methodology: https://510kreport.com/methodology