# K221317: S-Mono

- Pathway: 510(k) (Traditional)
- Applicant: Shinhung Mst Co., Ltd.
- Decided: Jan 13, 2023 after 252 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 K960026 (1996). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083067: MS System, Osstem Implant Co., Ltd. (2009) Summary page 4.
- K080594: MS System (Narrow Ridge), Osstem Implant Co., Ltd. (2008) Summary page 4.

## Indications for use
The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

Source page: https://510kreport.com/device/K221317
Methodology: https://510kreport.com/methodology