# K221752: Stella

- Pathway: 510(k) (Traditional)
- Applicant: Shinhung Mst Co., Ltd.
- Decided: Jun 4, 2023 after 353 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). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K123155: Luna Dental Implant System, Shinhung Mst Co., Ltd. (2013) Summary page 4.
- K160106: Luna Dental Implant System, Shinhung Mst Co., Ltd. (2016) Summary page 4.

## Indications for use
The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient’s chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

Source page: https://510kreport.com/device/K221752
Methodology: https://510kreport.com/methodology