# DIMPLO, Ltd.

- Location (FDA's records): Busan, KR
- FDA decisions: 1 (2025–2025): 1 510(k) clearance
- Product codes: DZE (1)
- Predicates its devices cite: 13 (0 its own); citations of its devices by later devices: 0 (0 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
- Cowellmedi Co., Ltd.: 3 (https://510kreport.com/company/cowellmedi)
- Dio Corporation: 2 (https://510kreport.com/company/dio)
- Dentium Co., Ltd.: 2 (https://510kreport.com/company/dentium)
- Neobiotech Co., Ltd.: 1 (https://510kreport.com/company/neobiotech)
- Hoowon Edi Co., Ltd.: 1 (https://510kreport.com/company/hoowon-edi)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)
- Ossvis Co., Ltd.: 1 (https://510kreport.com/company/ossvis)
- Oneday Biotech Co., Ltd.: 1 (https://510kreport.com/company/oneday-biotech)

## Recent decisions
- K251605: DIMPLO Implant System (Dec 22, 2025)

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