# K191443: MSDI Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Systems and Devices International, Ltd.
- Decided: Jun 26, 2020 after 393 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: 11 generations back to K960026 (1996). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162299: Spiral Shape Dental Implant System, Gp Implants (2017) Summary page 7.

## Most influential descendants
- K213677: Bonafix 2 Plus (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K191443
Methodology: https://510kreport.com/methodology