Manufacturer registered with FDA
JM Ortho Corporation
CHIYODA-KU, Japan. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 880 registrations outside the US
- Establishments
- 1Japan
Registered in 8 markets
Where regulators' registries name JM Ortho Corporation 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 | JM Ortho Corporation | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | JM Ortho Corporation | 42 | — | Pure Global AI |
| Japan | PMDA | Registration holder | 株式会社ＪＭ Ｏｒｔｈｏ | 28 | 2008–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JM ORTHO CORPORATION | 4 | 2018–2020 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | JM Ortho Corporation | 3 | 2014–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | JM Ortho Corporation | 1 | 2019–2019 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | JM ORTHO CORPORATION | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | JM ORTHO CORPORATION | 1 | 2025–2025 | 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 JM Ortho Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | Energy ChainEnergy ThreadK-2 O-RingTough-O | 2005 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | — | 2012 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | — | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JM ORTHO CORPORATIONFDA reg. 1000350450 | CHIYODA-KU Tokyo, Japan | Foreign exporter, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9071262). 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.