# Achimhai Medical Corporation

- Location (FDA's records): Hwaseong-Si, KR
- FDA decisions: 3 (2017–2021): 3 510(k) clearances
- Product codes: DZE (2), NHA (1)
- 510(k) review time since 2016: median 240 days, against 211 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 7 (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
- Nobel Biocare AB: 2 (https://510kreport.com/company/nobel-biocare)
- Dentium Co., Ltd.: 2 (https://510kreport.com/company/dentium)
- Megagen Implant Co., Ltd.: 1 (https://510kreport.com/company/megagen-implant)
- Neobiotech Co., Ltd.: 1 (https://510kreport.com/company/neobiotech)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)

## Recent decisions
- K200193: Kisses Plus Implant System (Aug 6, 2021)
- K172630: Kisses Plus Implant System (Apr 3, 2018)
- K170394: Kisses Mini (Oct 6, 2017)

Source page: https://510kreport.com/company/achimhai-medical