# K153521: IH Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Sewonmedix, Inc.
- Decided: Oct 14, 2016 after 311 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: 13 generations back to K894595 (1990). 76 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121995: TS Fixture System, Osstem Implant Co., Ltd. (2012) Summary page 5.
- K140507: Hiossen Prosthetic System, Osstem Implant Co., Ltd. (2014) Summary page 7.
- K123755: Multi Angled Abutment, Osstem Implant Co., Ltd. (2013) Summary page 7.
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 7.

## Most influential descendants
- K172100: URIS OMNI System (2018), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K231411: INNO SLA Submerged Hybrid Ti-Base System (2023), 1 descendant of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K222707: IH Implant System (2023), 1 descendant of its own

## Indications for use
IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Source page: https://510kreport.com/device/K153521
Methodology: https://510kreport.com/methodology