# Shofu Dental Corp.

- Location (FDA's records): San Marcos, CA
- FDA decisions: 97 (1981–2025): 97 510(k) clearances
- Names in FDA's records: Shofu Dental Corp. (59); Shofu Dental Corporation (38)
- Product codes: EBF (27), EMA (24), EIH (15), KLE (13), DZP (4), ELL (2), ELM (2), EJH (2), EJR (1), EKG (1), LBH (1), FHJ (1)
- 510(k) review time since 2016: median 110 days, against 125 for FDA's reviews in the same codes and years (14 of 21 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 11 (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
- Interdent, Inc.: 1 (https://510kreport.com/company/interdent)
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)
- GC America, Inc.: 1 (https://510kreport.com/company/gc-america)

## Firms that cite its devices most
- Kuraray America, Inc.: 2 (https://510kreport.com/company/kuraray-america)
- Ultradent Products Inc. / Oratech, LLC: 1 (https://510kreport.com/company/ultradent-products-oratech)
- Creamed GmbH & Co. Produktions- Und Handels KG: 1 (https://510kreport.com/company/creamed-co-produktions-und-handels)
- Schutz-Dental GmbH: 1 (https://510kreport.com/company/schutz-dental)
- Kuraray Medical Kurashiki Plant: 1 (https://510kreport.com/company/kuraray-medical-kurashiki-plant)
- Kuraray Noritake Dental, Inc.: 1 (https://510kreport.com/company/kuraray-noritake-dental)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)
- Kuraray Medical, Inc.: 1 (https://510kreport.com/company/kuraray-medical)

## Its most-cited devices
- K972292: Solidex (1997), cited by 3
- K953612: Imperva Fluorobond (1995), cited by 1
- K050401: Ceramage (2005), cited by 1
- K973247: Vintage Halo (1997), cited by 1
- K130841: Shofu Block HC (2013), cited by 1
- K111855: HY-Bond Resiglass (2011), cited by 1

## Recent decisions
- K252808: GlasIonomer FX-LC (Dec 9, 2025)
- K252165: Zirconomer P (Oct 28, 2025)
- K251470: ResiCem EX (Jul 11, 2025)
- K251578: Beautifil II (May 27, 2025)
- K233161: BeautiLink SA (Sep 28, 2023)
- K222253: GlasIonomer FX ULTRA (Sep 22, 2022)
- K213965: BeautiBond Xtreme (Mar 18, 2022)
- K212939: Vintage Prime Press (Mar 18, 2022)

Source page: https://510kreport.com/company/shofu-dental