# Maruchi

- Location (FDA's records): Wonju-Si, KR
- FDA decisions: 8 (2012–2023): 8 510(k) clearances
- Product codes: KIF (7), EJK (1)
- 510(k) review time since 2016: median 325 days, against 89 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 10 (5 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
- Innovative Bioceramix, Inc.: 3 (https://510kreport.com/company/innovative-bioceramix)
- Paxmed International: 1 (https://510kreport.com/company/paxmed-international)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)

## Firms that cite its devices most
- Prevest Denpro Limited: 2 (https://510kreport.com/company/prevest-denpro)
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)
- Genoss Co., Ltd.: 1 (https://510kreport.com/company/genoss)
- Inter-Med, Inc.: 1 (https://510kreport.com/company/inter-med)

## Its most-cited devices
- K170175: Endoseal Mta (2018), cited by 5
- K201799: CleaniCal (2021), cited by 2
- K133054: Endoseal (2014), cited by 1
- K112078: Endocem Mta (Mineral Trioxide Aggregate) (2012), cited by 1
- K202015: White ENDOSEAL MTA (2021), cited by 1

## Recent decisions
- K213757: Endocem MTA Premixed Regular (Feb 14, 2023)
- K212229: White Endoseal MTA (Aug 13, 2021)
- K202015: White ENDOSEAL MTA (Mar 24, 2021)
- K201799: CleaniCal (Feb 12, 2021)
- K170175: Endoseal Mta (Feb 26, 2018)
- K133054: Endoseal (May 12, 2014)
- K133042: Endocem ZR (May 12, 2014)
- K112078: Endocem Mta (Mineral Trioxide Aggregate) (Mar 19, 2012)

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