# K200188: DSI Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dsi Dental Solutions, Ltd.
- Decided: Apr 1, 2020 after 68 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: 9 generations back to K894595 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170372: SpiralTech Dental Implant System, Spiraltech Superior Dental Implants, Inc. (2017) Summary page 5.

## Indications for use
DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Source page: https://510kreport.com/device/K200188
Methodology: https://510kreport.com/methodology