# Spident Co., Ltd.

- Location (FDA's records): Incheon, KR
- FDA decisions: 22 (2009–2026): 22 510(k) clearances
- Product codes: EBF (7), EMA (5), KLE (3), KIF (2), DYH (2), EBG (1), ELW (1), EJK (1)
- 510(k) review time since 2016: median 79 days, against 87 for FDA's reviews in the same codes and years (7 of 14 faster)
- Predicates its devices cite: 20 (2 its own); citations of its devices by later devices: 4 (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
- Tokuyama Dental Corporation: 2 (https://510kreport.com/company/tokuyama-dental)
- GC America, Inc.: 2 (https://510kreport.com/company/gc-america)
- 3M Espe Dental Products: 2 (https://510kreport.com/company/3m-espe-dental-products)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)
- 3M Espe AG: 1 (https://510kreport.com/company/3m-espe)
- Voco GmbH: 1 (https://510kreport.com/company/voco)
- Premier Dental Products Co.: 1 (https://510kreport.com/company/premier-dental-products)

## Firms that cite its devices most
- Saremco Dental AG: 1 (https://510kreport.com/company/saremco-dental)
- Mediclus Co., Ltd.: 1 (https://510kreport.com/company/mediclus)

## Its most-cited devices
- K241445: K-Bond Universal (2024), cited by 1
- K134021: Estemp Implant, Estemp Clear (2014), cited by 1
- K092572: Core*IT Dual (2009), cited by 1
- K242675: FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (2024), cited by 1

## Recent decisions
- K262433: OrthoFit Aligner (OrthoFit Aligner A2) (Oct 13, 2026)
- K262983: EsTemp Implant (Sep 25, 2026)
- K262982: Core·it Dual (Sep 21, 2026)
- K262050: Vioseal X (Sep 11, 2026)
- K261129: OrthoFit (Jul 2, 2026)
- K250566: EsCem RMGI (Jun 20, 2025)
- K250317: EsFlow PLUS (May 30, 2025)
- K242702: VioSeal (Nov 7, 2024)

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