Data / Medical devices / Japan / Orbray Co., Ltd.
Orbray Co., Ltd.: FDA-registered device maker in Yokote-shi Akita, Japan, 1 510(k) clearance
Orbray Co., Ltd. is registered with the FDA (registration 3013513796) in Yokote-shi Akita, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 19, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013513796
- Address
- 12-1 Kamisakurazawa Sotonome, Yokote-shi Akita, Japan, 0130053
- Owner or operator
- Orbray Co Ltd (10053336)
- Roles
- Manufacturer
- First device listed
- November 22, 2016
- Registered through
- 2026
- Brand names listed
- LAYZIR DISC, SHOFU DISK ZR, LUCENT SUPRA, ZIRCONIA DISC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | 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 19, 2016 | K160203 | ADAMANT ZIRCONIA DISC | EIH | Substantially Equivalent | Adamant Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 19, 2016. 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.