# K222707: IH Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Sewonmedix, Inc.
- Decided: Jul 7, 2023 after 303 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: 14 generations back to K894595 (1990). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153521: IH Implant System, Sewonmedix, Inc. (2016) Summary page 4.

## Most influential descendants
- K240977: DenQ Sub SLA Implant System (2024), 0 descendants 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/K222707
Methodology: https://510kreport.com/methodology