# K173819: MyPlant II Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: Aug 9, 2018 after 234 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 K894844 (1990). 23 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143539: Dental Implant OKTAGON Bone Level, Hager& Meisinger GmbH (2015) Summary page 4.

## Most influential descendants
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K202832: Implacil Implant System (2021), 0 descendants of its own
- K192839: DSP Implant System (2021), 0 descendants of its own

## Indications for use
The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively with MyPlant II abutments and prosthetic components. The abutments serve for prosthetic restorations and can include individual Crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In case of appropriate primary stability (35 Nem), immediate temporary restoration with appropriate occlusal load can also be performed.

Source page: https://510kreport.com/device/K173819
Methodology: https://510kreport.com/methodology