Manufacturer registered with FDA
Orbray Co Ltd
Yokote-shi, Japan. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 217 registrations outside the US
- Establishments
- 2Japan
Registered in 2 markets
Where regulators' registries name Orbray 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 | Orbray Co Ltd | 1 device types | — | Below |
| Japan | PMDA | Registration holder | Ｏｒｂｒａｙ株式会社 | 17 | 2012–2024 | 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 Orbray 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | LayZir DiscLAYZIR DISC, SHOFU DISK ZR, LUCENT SUPRA, ZIRCONIA DISCSHOFU DISK ZR Lucent SupraZirconia Disc | 2016 |
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
Orbray Co Ltd 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: Adamant Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Oct 2016 | K160203 | ADAMANT ZIRCONIA DISC | Adamant Co., Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Orbray Co LTDFDA reg. 3012867029 | Tokyo, Japan | Specification developer |
| Orbray Co., Ltd.FDA reg. 3013513796 | Yokote-shi Akita, Japan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053336, 10053339). 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.