# Dentalmax Co., Ltd.

- Location (FDA's records): Cheonan-Si, KR
- FDA decisions: 3 (2018–2024): 3 510(k) clearances
- Product codes: EIH (3)
- 510(k) review time since 2016: median 158 days, against 131 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 5 (1 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
- GC America, Inc.: 1 (https://510kreport.com/company/gc-america)
- Dental Direkt of Amerika UG (Haftungsbeschraenkt): 1 (https://510kreport.com/company/dental-direkt-of-amerika-ug-haftungsbeschraenkt)
- Dental Direkt GmbH: 1 (https://510kreport.com/company/dental-direkt)

## Firms that cite its devices most
- Mediclus Co., Ltd.: 2 (https://510kreport.com/company/mediclus)
- Denken-Highdental Co., Ltd.: 1 (https://510kreport.com/company/denken-highdental)
- Osstem Implant Co., Ltd.: 1 (https://510kreport.com/company/osstem-implant)

## Its most-cited devices
- K171585: LUXEN Zr, LUXEN Smile (2018), cited by 4
- K241151: Luxen 5G (2024), cited by 1

## Recent decisions
- K241151: Luxen 5G (Sep 30, 2024)
- K212548: LUXEN CL Dental Liquid (Dec 6, 2021)
- K171585: LUXEN Zr, LUXEN Smile (Oct 31, 2018)

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