# Hiossen, Inc.

- Location (FDA's records): Fariless Hills, PA
- FDA decisions: 26 (2009–2026): 26 510(k) clearances
- Product codes: DZE (15), NHA (9), NPM (1), EKX (1)
- 510(k) review time since 2016: median 240 days, against 219 for FDA's reviews in the same codes and years (5 of 15 faster)
- Predicates its devices cite: 49 (23 its own); citations of its devices by later devices: 37 (23 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Osstem Implant Co., Ltd.: 19 (https://510kreport.com/company/osstem-implant)
- Institut Straumann AG: 2 (https://510kreport.com/company/institut-straumann)
- Implant Innovations, Inc.: 1 (https://510kreport.com/company/implant-innovations)
- Tellos Medical AB: 1 (https://510kreport.com/company/tellos-medical)
- Biomet 3i, Inc.: 1 (https://510kreport.com/company/biomet-3i)
- Dio Department Dsi, Inc.: 1 (https://510kreport.com/company/dio-department-dsi)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)

## Firms that cite its devices most
- Osstem Implant Co., Ltd.: 9 (https://510kreport.com/company/osstem-implant)
- Idis Co., Ltd.: 1 (https://510kreport.com/company/idis)
- Truabutment, Inc.: 1 (https://510kreport.com/company/truabutment)
- Ossvis Co., Ltd.: 1 (https://510kreport.com/company/ossvis)
- Medical Instinct Deutschland GmbH: 1 (https://510kreport.com/company/medical-instinct-deutschland)
- Newton Implant Systems, Inc.: 1 (https://510kreport.com/company/newton-implant-systems)

## Its most-cited devices
- K101096: HT Iii SA Fixture System (2010), cited by 7
- K140934: Hiossen Implant System (2014), cited by 6
- K203360: EK Implants and Abutments System (2022), cited by 5
- K123627: ET Smartfit Abutment (2013), cited by 3
- K103537: ET Iii SA Ultra Wide System (2011), cited by 2
- K132067: Multi Angled Abutment System (2013), cited by 2

## Recent decisions
- K253372: ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (May 14, 2026)
- K251427: EK Multi Angled 30 Abutment (Jan 29, 2026)
- K241003: HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (Jan 8, 2025)
- K240232: EK D3.3 and Ultra Wide Implants (Sep 13, 2024)
- K233389: EK Digital Abutments (May 29, 2024)
- K222636: ET Abutment System (Apr 28, 2023)
- K203360: EK Implants and Abutments System (Jan 7, 2022)
- K191751: EM Provisional (Dec 16, 2019)

Source page: https://510kreport.com/company/hiossen