# K171297: AR_N Type Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biotem Co., Ltd.
- Decided: Jan 31, 2018 after 274 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 K894595 (1990). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113554: Cmi Implant IS System, Neobiotech Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K190641: AR_N SLA Type Implant System (2020), 0 descendants of its own

## Indications for use
AR_N 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. AR_N Type Implant System is for two stage surgical procedures. It is intended for delayed load.

Source page: https://510kreport.com/device/K171297
Methodology: https://510kreport.com/methodology