# K080594: MS System (Narrow Ridge)

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 3, 2008 after 184 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: 10 generations back to K960026 (1996). 23 ancestors in all.
42 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071235: Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13, Zimmer Dental, Inc. (2007) Summary page 1.
- K070857: Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM, Nobel Biocare AB (2007) Summary page 1.
- K072959: MS System (Denture), Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- K083067: MS System (2009), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own

## Indications for use
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) are intended for single use only and not for immediate loading.

Source page: https://510kreport.com/device/K080594
Methodology: https://510kreport.com/methodology