Registered with FDA
Orich Medical Equipment (Tianjin) Co., Ltd.
Tianjin, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Orich Medical Equipment (Tianjin) 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 | Lister | Orich Medical Equipment (Tianjin) Co., Ltd. | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. | 1 | 2019–2019 | 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 Orich Medical Equipment (Tianjin) 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 |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | Intra Os 70Intra OS DGPanaramic | 2017 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | Panaramic | 2017 |
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
Orich Medical Equipment (Tianjin) 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: Planmeca Oy (1), Blue X Imaging Srl (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Jun 2005 | K051464 | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) | Planmeca Oy | EHD Extraoral with Timer X-Ray Unit |
| 8 Jul 2003 | K031118 | INTRAOS 70 | Blue X Imaging Srl | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.FDA reg. 3009608361 | Tianjin, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040720). 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.