# Cowellmedi Co., Ltd.

- Location (FDA's records): Busan, KR
- FDA decisions: 14 (2004–2025): 14 510(k) clearances
- Product codes: DZE (9), NHA (4), NPK (1)
- 510(k) review time since 2016: median 248 days, against 147 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 48 (7 its own); citations of its devices by later devices: 13 (7 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
- Nobelpharma USA, Inc.: 6 (https://510kreport.com/company/nobelpharma-usa)
- Nobel Biocare Uas, Inc.: 5 (https://510kreport.com/company/nobel-biocare-uas)
- Implant Innovations, Inc.: 5 (https://510kreport.com/company/implant-innovations)
- Neobiotech Co., Ltd.: 4 (https://510kreport.com/company/neobiotech)
- Osstem Implant Co., Ltd.: 3 (https://510kreport.com/company/osstem-implant)
- Truabutment, Inc.: 2 (https://510kreport.com/company/truabutment)
- Megagen Co., Ltd.: 2 (https://510kreport.com/company/megagen)
- Dentium Co., Ltd.: 2 (https://510kreport.com/company/dentium)

## Firms that cite its devices most
- DIMPLO, Ltd.: 3 (https://510kreport.com/company/dimplo)
- Megagen Co., Ltd.: 1 (https://510kreport.com/company/megagen)
- Csm Implant: 1 (https://510kreport.com/company/csm-implant)
- Neobiotech Co., Ltd.: 1 (https://510kreport.com/company/neobiotech)

## Its most-cited devices
- K201323: INNO SLA Submerged Implant System (2022), cited by 2
- K071148: Atlas Implant System (2008), cited by 2
- K132242: Inno Sla Submerged Implant System (2013), cited by 2
- K041655: Bio Plant System (Implants and Abutments) (2004), cited by 2
- K090054: Atlas Implant System - Wide Plus (2009), cited by 1
- K231411: INNO SLA Submerged Hybrid Ti-Base System (2023), cited by 1

## Recent decisions
- K242287: SFIT Abutment (Sep 16, 2025)
- K241127: INNO SLA Mini Plus® Implant System (Dec 27, 2024)
- K231411: INNO SLA Submerged Hybrid Ti-Base System (Dec 20, 2023)
- K232546: Meta G UCLA Abutment (Nov 21, 2023)
- K231395: INNO SLA Submerged Narrow Implant System (Oct 18, 2023)
- K211554: InnoGenic Non-resorbable Membrane (Feb 24, 2023)
- K201323: INNO SLA Submerged Implant System (Jan 25, 2022)
- K132242: Inno Sla Submerged Implant System (Dec 6, 2013)

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