Manufacturer registered with FDA
MyoHealth Technologies, LLC
Portland, OR, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What MyoHealth Technologies, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Myoaligner Appliance | 2024 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Myoaligner Appliance | 2024 |
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
MyoHealth Technologies, LLC 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: Huge Dental Material Co., Ltd. (1), The Argen Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Nov 2020 | K201683 | PMMA Block | Huge Dental Material Co., Ltd. | EBG Resin Temporary Crown and Bridge |
| 31 Jul 2014 | K140894 | ARGEN PMMA | The Argen Corporation | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MYOHEALTH TECHNOLOGIES, LLCFDA reg. 3030686055 | Portland, OR, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090435). 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.