# K223395: Luna Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Shinhung Mst Co., Ltd.
- Decided: Feb 3, 2023 after 87 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123155: Luna Dental Implant System, Shinhung Mst Co., Ltd. (2013) Summary page 4.
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.

## 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. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K223395
Methodology: https://510kreport.com/methodology