Data / Medical devices / Agent, Tooth Bonding, Resin / Japan
FDA-registered makers of Agent, Tooth Bonding, Resin in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make Agent, Tooth Bonding, Resin (product code KLE). 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
- Agent, Tooth Bonding, Resin
- Product code
- KLE
- Country
- Japan
Makers of Agent, Tooth Bonding, Resin in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kuraray Noritake Dental Niigata Plant | TAINAI Niigata, Japan | Manufacturer | 15 | December 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shofu Inc. | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Manufacturer | 8 | March 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 6 | June 29, 2004 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Complaint file establishment, Manufacturer | 6 | October 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| TOKUYAMA DENTAL CORPORATION Kashima Factory | Kamisu-shi Ibaraki, Japan | Manufacturer | 5 | May 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer | 4 | June 29, 2004 | 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.