Manufacturer registered with FDA
Nipro Corporation
Settsu, Japan. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6139 registrations outside the US
- Establishments
- 2Japan
Registered in 6 markets
Where regulators' registries name Nipro Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Nipro Corporation | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | NIPRO MEDICAL INDUSTRIES LTD.NIPRO CORPORATION | 55 | 1982–2019 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NIPRO CORPORATIONNIPRO MEDICAL INDUSTRIES LTD. · NIPRO MEDICAL INDUSTRIES LTD | 36 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NIPRO CORPORATIONNIPRO MEDICAL INDUSTRIES LTD. | 24 | 2003–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Nipro CorporationNIPRO CO. · NIPRO CORPORATION | 14 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NIPRO CORPORATIONNIPRO MEDICAL INDUSTRIES LTD · NIPRO MEDICAL INDUSTRIES LTDA | 10 | 2006–2026 | 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
Devices listed with FDA
What Nipro Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental Needle | 2006 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Nipro Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Exel Intl. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Apr 1986 | K861150 | EXEL DENTAL NEEDLE | Exel Intl. | DZM Dental Needle |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NIPRO CORPORATIONFDA reg. 3000247873 | Settsu Osaka, Japan | Foreign exporter |
| NIPRO MEDICAL INDUSTRIES LTD.FDA reg. 9611446 | TATEBAYASHI-SHI Gunma, Japan | Contract manufacturer, Manufacturer |
Other names on FDA records
Nipro Medical Industries Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030375). 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.