Data / Medical devices / Cement, Dental / Japan
FDA-registered makers of Cement, Dental in Japan: 9 establishments
9 establishments in Japan are registered with the FDA to make Cement, Dental (product code EMA). 9 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
- Cement, Dental
- Product code
- EMA
- Country
- Japan
Makers of Cement, Dental in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| GC Corp. | ITABASHI-KU Tokyo, Japan | Exporter to the US, Manufacturer | 27 | May 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer, Repackager or relabeler | 24 | May 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 17 | December 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Kuraray Noritake Dental Niigata Plant | TAINAI Niigata, Japan | Manufacturer | 5 | June 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 3 | July 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| GC Asahi Corporation | Aichi, Japan | Manufacturer | 2 | May 23, 1995 | 0 | 0 | 0 | api.fda.gov |
| Neo Dental Chemical Products Co., Ltd. | Nagano, Japan | Manufacturer | 1 | July 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Sun Medical Co., Ltd. | Moriyama Shiga, Japan | Complaint file establishment, Manufacturer | 1 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| TOKUYAMA DENTAL CORPORATION Kashima Factory | Kamisu-shi Ibaraki, Japan | Manufacturer | 1 | June 17, 2015 | 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.