# Mediclus Co., Ltd.

- Location (FDA's records): Cheongju-Si, KR
- FDA decisions: 16 (2023–2026): 16 510(k) clearances
- Product codes: EBF (5), KIF (4), KLE (2), MVL (1), EJK (1), EBC (1), EIH (1), EMA (1)
- 510(k) review time since 2016: median 108 days, against 84 for FDA's reviews in the same codes and years (4 of 13 faster)
- Predicates its devices cite: 17 (2 its own); citations of its devices by later devices: 3 (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
- 3M Espe Dental Products: 3 (https://510kreport.com/company/3m-espe-dental-products)
- Dentalmax Co., Ltd.: 2 (https://510kreport.com/company/dentalmax)
- Angelus Industria DE Produtos Odontologicos S/A: 1 (https://510kreport.com/company/angelus-industria-de-produtos-odontologicos-s-a)
- Dmg USA, Inc.: 1 (https://510kreport.com/company/dmg-usa)
- Pac-Dent International, Inc.: 1 (https://510kreport.com/company/pac-dent-international)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)
- Meta Biomed Co., Ltd.: 1 (https://510kreport.com/company/meta-biomed)
- Voco GmbH: 1 (https://510kreport.com/company/voco)

## Firms that cite its devices most
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)

## Its most-cited devices
- K243353: One-Fil Putty (2025), cited by 1
- K241147: Any-Com (2024), cited by 1
- K230465: Hi-Bond Universal (2023), cited by 1

## Recent decisions
- K262074: Any-Zircos (Aug 21, 2026)
- K254201: Any-Cem (Aug 13, 2026)
- K261728: One-Fil LC (Jul 21, 2026)
- K260485: Any-Etch (May 14, 2026)
- K260819: Any-Com Seal (May 1, 2026)
- K253797: One-Stop (Feb 27, 2026)
- K253167: Any-Paste (Jan 12, 2026)
- K252465: Any-Core (Dec 5, 2025)

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