# K123155: Luna Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Shinhung Mst Co., Ltd.
- Decided: Oct 31, 2013 after 387 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: 2 generations back to K931767 (1994). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041368: Dentium CO., LTD. Implantium, Dentium Co., Ltd. (2004) Summary page 1.
- K052957: Implantium Prosthetics, Dentium Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K172345: IU Implant System (2018), 2 descendants of its own
- K221972: Warantec Custom Abutment (2023), 0 descendants of its own
- K221752: Stella (2023), 0 descendants of its own
- K221969: IU Implant System Abutment (2023), 0 descendants of its own
- K223395: Luna Dental Implant System (2023), 0 descendants of its own

## Indications for use
The Luna 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

Source page: https://510kreport.com/device/K123155
Methodology: https://510kreport.com/methodology