Data / Medical devices / United States / Myohealth Technologies, LLC
Myohealth Technologies, LLC: FDA-registered device maker in Portland, OR, United States, 3 510(k) clearances
Myohealth Technologies, LLC is registered with the FDA (registration 3030686055) in Portland, OR, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030686055
- Address
- 13765 NW Cornell Rd Suite 150, Portland, OR, United States, 97229
- Owner or operator
- MyoHealth Technologies, LLC (10090435)
- Roles
- Manufacturer
- First device listed
- March 27, 2024
- Registered through
- 2026
- Brand names listed
- Myoaligner Appliance
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Migraine/Tension Headache | OCO | U | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 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 |
|---|---|---|---|---|---|---|
| February 2, 2024 | K230548 | Myoaligner Appliance | MQC | Substantially Equivalent | Myohealth Technologies, LLC | accessdata.fda.gov |
| November 3, 2020 | K201683 | PMMA Block | EBG | Substantially Equivalent | Huge Dental Material Co., Ltd. | accessdata.fda.gov |
| July 31, 2014 | K140894 | ARGEN PMMA | EBG | Substantially Equivalent | The Argen Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Mouthguard, Prescription
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Mouthguard, Migraine/Tension Headache
Updated February 2, 2024. 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.