# Osstem Implant Co., Ltd.

- Location (FDA's records): Busan, KR
- FDA decisions: 68 (2006–2026): 68 510(k) clearances
- Product codes: DZE (27), NHA (18), ELW (5), EHD (3), OAS (3), DZL (3), JEY (3), OAT (2), EIA (2), EIH (2)
- 510(k) review time since 2016: median 158 days, against 159 for FDA's reviews in the same codes and years (11 of 26 faster)
- Predicates its devices cite: 149 (104 its own); citations of its devices by later devices: 216 (104 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hiossen, Inc.: 9 (https://510kreport.com/company/hiossen)
- Institut Straumann AG: 4 (https://510kreport.com/company/institut-straumann)
- Straumann USA: 4 (https://510kreport.com/company/straumann-usa)
- Neobiotech Co., Ltd.: 3 (https://510kreport.com/company/neobiotech)
- Astra Tech, Inc.: 3 (https://510kreport.com/company/astra-tech)
- Osstem Co., Ltd.: 2 (https://510kreport.com/company/osstem)
- Jeil Medical Corporation: 2 (https://510kreport.com/company/jeil-medical)
- Osstem Germany GmbH: 2 (https://510kreport.com/company/osstem-germany)

## Firms that cite its devices most
- Hiossen, Inc.: 19 (https://510kreport.com/company/hiossen)
- Truabutment, Inc.: 10 (https://510kreport.com/company/truabutment)
- Neobiotech Co., Ltd.: 9 (https://510kreport.com/company/neobiotech)
- Dentis Co., Ltd.: 5 (https://510kreport.com/company/dentis)
- Shinhung Mst Co., Ltd.: 5 (https://510kreport.com/company/shinhung-mst)
- Kj Meditech Co., Ltd.: 5 (https://510kreport.com/company/kj-meditech)
- Izenimplant Co., Ltd.: 4 (https://510kreport.com/company/izenimplant)
- Sewonmedix, Inc.: 4 (https://510kreport.com/company/sewonmedix)

## Its most-cited devices
- K161689: OSSTEM Implant System - Abutment (2017), cited by 13
- K121995: TS Fixture System (2012), cited by 11
- K120847: ET/SS Implant System (2012), cited by 11
- K182091: Osstem Abutment System (2019), cited by 11
- K063861: GS System (2007), cited by 10
- K062030: US System (2006), cited by 10

## Recent decisions
- K251434: Healing Abutment System (Mar 4, 2026)
- K251569: Bone Screw (Aug 13, 2025)
- K242521: Estar-ZE (Nov 20, 2024)
- K233806: T2 Plus (Sep 6, 2024)
- K233194: TS Abutment System (Feb 20, 2024)
- K232220: SS Abutment System (Dec 5, 2023)
- K232012: N1 (Nov 28, 2023)
- K222778: Osstem Implant System (Sep 23, 2023)

Source page: https://510kreport.com/company/osstem-implant