Manufacturer registered with FDA
Myotronics-Noromed, Inc
KENT, WA, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 312 registrations outside the US
- Establishments
- 1United States
Registered in 3 markets
Where regulators' registries name Myotronics-Noromed, Inc 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 | Myotronics-Noromed, Inc | 3 device types | — | Below |
| South Korea | MFDS | Manufacturer | Myotronics-Noromed, Inc.Myotronics-Noromed, Inc | 7 | 2002–2005 | Pure Global AI |
| Canada | Health Canada | Registration holder | MYOTRONICS-NOROMED, INC. | 5 | 1999–2024 | 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 Myotronics-Noromed, Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | TERMINUS ARTICULATOR | 1992 |
| Dental Sonography Device for Monitoring Jaw SoundsNFQ · Class 1 | — | Maker | ESG-1 ELECTROSONOGRAM | 2005 |
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Maker | ESG-1 ELECTROSONOGRAM | 2005 |
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
Myotronics-Noromed, Inc 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: Myo-Tronics, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Apr 1997 | K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | Myo-Tronics, Inc. | NFQ Dental Sonography Device for Monitoring Jaw Sounds |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MYOTRONICS-NOROMED, INC.FDA reg. 3014732 | KENT, WA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 3014732). 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.