# K162867: MagDen Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Shinhung Mst Co., Ltd.
- Decided: Jul 26, 2017 after 286 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: 1 generation back to K031106 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 4.

## Most influential descendants
- K192614: Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (2020), 0 descendants of its own

## Indications for use
The MagDen Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. The MagDen Fixture devices are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The MagDen Fixture devices are indicated for immediate loading when good primary stability is achieved.

Source page: https://510kreport.com/device/K162867
Methodology: https://510kreport.com/methodology