# Meta Biomed Co., Ltd.

- Location (FDA's records): Cheongju-Si, KR
- FDA decisions: 25 (2003–2024): 25 510(k) clearances
- Names in FDA's records: Meta Biomed Co., Ltd. (21); Meta Biomed, Inc. (4)
- Product codes: KIF (9), EBF (4), EMA (2), KLE (2), EBG (2), EHD (2), LYC (1), EKX (1), ELW (1), MQV (1)
- 510(k) review time since 2016: median 100 days, against 115 for FDA's reviews in the same codes and years (4 of 13 faster)
- Predicates its devices cite: 57 (7 its own); citations of its devices by later devices: 29 (7 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
- Bisco, Inc.: 4 (https://510kreport.com/company/bisco)
- Kuraray Medical, Inc.: 3 (https://510kreport.com/company/kuraray-medical)
- Pulpdent Corp.: 3 (https://510kreport.com/company/pulpdent)
- Dentsply Intl.: 3 (https://510kreport.com/company/dentsply-intl)
- Biomatlante: 2 (https://510kreport.com/company/biomatlante)
- Dentsply Interntional: 2 (https://510kreport.com/company/dentsply-interntional)
- Innovative Bioceramix, Inc.: 2 (https://510kreport.com/company/innovative-bioceramix)
- Coltene/Whaledent, Inc.: 2 (https://510kreport.com/company/coltene-whaledent)

## Firms that cite its devices most
- Digimed Co., Ltd.: 3 (https://510kreport.com/company/digimed)
- DiaDent Group International: 3 (https://510kreport.com/company/diadent-group-international)
- Km Corporation: 3 (https://510kreport.com/company/km)
- Vericom Co., Ltd.: 2 (https://510kreport.com/company/vericom)
- Meta Systems Co., Ltd.: 1 (https://510kreport.com/company/meta-systems)
- Genoray Co., Ltd.: 1 (https://510kreport.com/company/genoray)
- Raypia Co., Ltd.: 1 (https://510kreport.com/company/raypia)
- Micro-Mega Societe Anonyme: 1 (https://510kreport.com/company/micro-mega-societe-anonyme)

## Its most-cited devices
- K132041: Rextar X (2013), cited by 6
- K042769: Adseal Root Canal Sealer (2004), cited by 5
- K032603: Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling (2003), cited by 4
- K032605: Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling (2003), cited by 3
- K190503: CeraSeal (2019), cited by 2
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), cited by 2

## Recent decisions
- K242014: Jet Flow Bulk (Oct 8, 2024)
- K232299: CeraPutty (Sep 29, 2023)
- K230010: ADSEAL Plus (Apr 13, 2023)
- K230009: EZ Bond Universal (Mar 3, 2023)
- K210904: Metapaste Plus (Jun 30, 2021)
- K202617: Metapex Plus (Apr 14, 2021)
- K191991: Ezfil (Mar 5, 2020)
- K190724: MD-Temp Plus (Jul 3, 2019)

Source page: https://510kreport.com/company/meta-biomed