# K171185: IR Type Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biotem Co., Ltd.
- Decided: Dec 1, 2017 after 221 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: 6 generations back to K894595 (1990). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062051: SS System, Osstem Implant Co., Ltd. (2006) Summary page 4.

## Most influential descendants
- K222144: IR SLA Type Implant System (2023), 0 descendants of its own

## Indications for use
IR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IR Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR Implant System is intended only for straight placement with no correction of angulation.

Source page: https://510kreport.com/device/K171185
Methodology: https://510kreport.com/methodology