# K122171: MS SA Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Nov 16, 2012 after 116 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). 44 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 47 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 1.
- K061176: Straumann Dental Implants, Institut Straumann AG (2006) Summary page 1.

## Most influential descendants
- K191201: EM SA Implant System (2019), 1 descendant of its own
- K242379: LL Implant System (2024), 0 descendants of its own

## Indications for use
The MIS SA Implant (Denture) is intended to be placed in the bane of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patients chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading. The MS SA Implant (Narrow Ridge) is intended to use in the treatment of mhissing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing flunction in partially edentulous patients. The MIS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.

Source page: https://510kreport.com/device/K122171
Methodology: https://510kreport.com/methodology