Data / Medical devices / Japan / Nimi Chemical Industrial Co., Ltd.
Nimi Chemical Industrial Co., Ltd.: FDA-registered device maker in Kiryu Gunma, Japan, 1 510(k) clearance
Nimi Chemical Industrial Co., Ltd. is registered with the FDA (registration 3003941201) in Kiryu Gunma, Japan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003941201
- Address
- 4-13 Yokoyama-cho, Kiryu Gunma, Japan, 376-0055
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Manufacturer
- First device listed
- January 16, 2004
- Registered through
- 2026
- Brand names listed
- GC BITE COMPOUND, GC Tri Plaque ID Gel, ISO Functional, SALIVA CHECK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Plaque Disclosing Kit | NYH | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2002 | K022430 | ISO FUNCTIONAL | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Wax, Dental, Intraoral
- All makers of Plaque Disclosing Kit
Updated October 18, 2002. 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.