Manufacturer registered with FDA
Osada Electric Co., Ltd.
TOKYO, Japan. Lists 3 dental device types with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 21985–1994
- Markets registered in
- 412 registrations outside the US
- Establishments
- 2Japan, United States
510(k) clearances per year, 1980–2026
Registered in 4 markets
Where regulators' registries name Osada Electric 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 | Manufacturer | Osada Electric Co., Ltd. | 2 clearances | 1985–1994 | Below |
| Taiwan | TFDA | Manufacturer | OSADA ELECTRIC CO. LTDOSADA ELECTRIC CO., LTD | 6 | 1978–2019 | Pure Global AI |
| South Korea | MFDS | Manufacturer | OSADA ELECTRIC CO.,LTDOsada Electric Co., Ltd | 4 | 2002–2007 | Pure Global AI |
| Israel | AMAR | Manufacturer | OSADA ELECTRIC CO. LTD.Osada Electric Co.Ltd. | 2 | — | 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 Osada Electric Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ac-Powered Bone SawDZH · Class 2 | — | Maker | OSADA SAW, BONE, AC POWERED | 2007 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | OSADA HANDPIECE, DIRECT DRIVE, AC-POWERED | 2007 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | OSADA SCALER, ULTRASONIC | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Osada Electric Co., Ltd. as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSADA ELECTRIC CO., LTD.FDA reg. 2832 | SHINAGAWA-KU Tokyo, Japan | Manufacturer |
| OSADA, INC.FDA reg. 2020943 | LOS ANGELES, CA, United States | Repacker / relabeler |
Other names on FDA records
Osada, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030228). 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.