Data / Medical devices / Material, Tooth Shade, Resin / Japan
FDA-registered makers of Material, Tooth Shade, Resin in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Material, Tooth Shade, Resin (product code EBF). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Material, Tooth Shade, Resin
- Product code
- EBF
- Country
- Japan
Makers of Material, Tooth Shade, Resin in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 20 | January 9, 2019 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 17 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Kuraray Noritake Dental Niigata Plant | TAINAI Niigata, Japan | Manufacturer | 13 | November 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 12 | August 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| TOKUYAMA DENTAL CORPORATION Kashima Factory | Kamisu-shi Ibaraki, Japan | Manufacturer | 8 | February 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer | 3 | November 18, 2004 | 0 | 0 | 0 | api.fda.gov |
| GC Asahi Corporation | Aichi, Japan | Manufacturer | 1 | March 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shiga Shofu Inc. | Koka Shiga, Japan | Contract manufacturer, Manufacturer | 1 | February 5, 2021 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.