# K083067: MS System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Feb 2, 2009 after 110 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: 11 generations back to K960026 (1996). 24 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072959: MS System (Denture), Osstem Implant Co., Ltd. (2008) Summary page 1.
- K080594: MS System (Narrow Ridge), Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K122171: MS SA Implant System (2012), 2 descendants of its own
- K191201: EM SA Implant System (2019), 1 descendant of its own
- K133050: One Plus Implant System (2014), 1 descendant of its own
- K241127: INNO SLA Mini Plus® Implant System (2024), 0 descendants of its own
- K242379: LL Implant System (2024), 0 descendants of its own

## Indications for use
The MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only. The MS System (Narrow Ridge) 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. MS System (Narrow Ridge) is intended for single use only. It is not for immediate loading.

Source page: https://510kreport.com/device/K083067
Methodology: https://510kreport.com/methodology