Data / Medical devices / Resin, Denture, Relining, Repairing, Rebasing / Japan
FDA-registered makers of Resin, Denture, Relining, Repairing, Rebasing in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make Resin, Denture, Relining, Repairing, Rebasing (product code EBI). 6 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
- Resin, Denture, Relining, Repairing, Rebasing
- Product code
- EBI
- Country
- Japan
Makers of Resin, Denture, Relining, Repairing, Rebasing in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 3 | July 9, 1999 | 0 | 0 | 0 | api.fda.gov |
| TOKUYAMA DENTAL CORPORATION Kashima Factory | Kamisu-shi Ibaraki, Japan | Manufacturer | 3 | October 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Yamahachi Dental MFG. Co. | Gamagori City Aichi, Japan | Complaint file establishment, Specification developer | 3 | March 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Exporter to the US, Manufacturer | 2 | March 3, 2016 | 0 | 0 | 0 | api.fda.gov |
| DENKEN-HIGHDENTAL Co., Ltd. | Kyoto, Japan | Complaint file establishment, Manufacturer | 1 | July 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer | 1 | March 3, 2016 | 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.