# K150537: MiNi Internal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Jul 21, 2015 after 140 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: 12 generations back to K894595 (1990). 150 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 5.

## Most influential descendants
- K170394: Kisses Mini (2017), 0 descendants of its own

## Indications for use
The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.

Source page: https://510kreport.com/device/K150537
Methodology: https://510kreport.com/methodology