Not currently registered with FDA under this name
Kamemizu Chemical Industry Co., Ltd.
Neyagawa, Japan. Named as applicant on 1 dental 510(k) clearance between 2025 and 2025. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12025–2025
- Markets registered in
- 23 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Kamemizu Chemical Industry Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Kamemizu Chemical Industry Co., Ltd. | 1 clearances | 2025–2025 | Below |
| South Korea | MFDS | Manufacturer | KAMEMIZU Chemical Industry Co., LTD.Kamemizu Chemical Industry Co. ,Ltd · Kamemizu Chemical Industry Co., LTD | 3 | 2000–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Kamemizu Chemical Industry Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Sep 2025 | K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | EBI Rebasing Repairing Relining Denture Resin |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.