# Warantec Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 4 (2009–2023): 4 510(k) clearances
- Product codes: NHA (2), DZE (2)
- 510(k) review time since 2016: median 320 days, against 147 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dentium Co., Ltd.: 6 (https://510kreport.com/company/dentium)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)
- Elos Medtech Pinol A/S: 1 (https://510kreport.com/company/elos-medtech-pinol-a-s)
- Osstem Co., Ltd.: 1 (https://510kreport.com/company/osstem)
- Shinhung Mst Co., Ltd.: 1 (https://510kreport.com/company/shinhung-mst)

## Firms that cite its devices most
- Truabutment, Inc.: 2 (https://510kreport.com/company/truabutment)
- Cowellmedi Co., Ltd.: 1 (https://510kreport.com/company/cowellmedi)
- Bhdental, Ltd.: 1 (https://510kreport.com/company/bhdental)

## Its most-cited devices
- K081748: Oneplant Dental Implant System (2009), cited by 4
- K172345: IU Implant System (2018), cited by 2

## Recent decisions
- K221972: Warantec Custom Abutment (Oct 2, 2023)
- K221969: IU Implant System Abutment (May 12, 2023)
- K172345: IU Implant System (Jun 18, 2018)
- K081748: Oneplant Dental Implant System (Mar 27, 2009)

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