Data / Medical devices / Japan / Shiga Shofu Inc.
Shiga Shofu Inc.: FDA-registered device maker in Koka Shiga, Japan, 1 510(k) clearance
Shiga Shofu Inc. is registered with the FDA (registration 3011814610) in Koka Shiga, Japan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 5, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011814610
- Address
- 2296 Kinose, Shigaraki-cho, Koka Shiga, Japan, 529-1802
- Owner or operator
- SHOFU INC. (9056340)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 24, 2012
- Registered through
- 2026
- Brand names listed
- SHOFU BLOCK HC, SHOFU BLOCK HC HARD, SHOFU DISK HC, VERACIA, VERACIA SA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Contract manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 2021 | K200470 | Shofu Block HC Hard | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Denture, Plastic, Teeth
Updated February 5, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.