Data / Medical devices / Japan / Setagaya Seiki Co., Ltd.
Setagaya Seiki Co., Ltd.: FDA-registered device maker in Yonezawa-shi Yamagata, Japan, 1 510(k) clearance
Setagaya Seiki Co., Ltd. is registered with the FDA (registration 3010388675) in Yonezawa-shi Yamagata, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 14, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010388675
- Address
- 5-4862-11 Hachimanpara, Yonezawa-shi Yamagata, Japan, 9921128
- Owner or operator
- Setagaya Seiki Co., Ltd. (10043790)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- October 31, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Exporter to the US, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 14, 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS | Substantially Equivalent | Pac-Dent International (Suzhou), Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 14, 2003. 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.