Manufacturer registered with FDA
Myofunctional Research Co. Usa Inc.
Rancho Cucamonga, CA, United States. Lists 5 dental device types with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 12
- 510(k) clearances
- 31993–2026
- Markets registered in
- 12125 registrations outside the US
- Establishments
- 2Australia, United States
510(k) clearances per year, 1990–2026
Registered in 12 markets
Where regulators' registries name Myofunctional Research Co. Usa 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 | Myofunctional Research Co. Usa Inc. | 3 clearances | 1993–2026 | Below |
| South Korea | MFDS | Manufacturer | Myofunctional Research Co. | 28 | 2013–2015 | Pure Global AI |
| Canada | Health Canada | Registration holder | MYOFUNCTIONAL RESEARCH CO. PTY LTD. | 25 | 2016–2023 | Pure Global AI |
| Australia | TGA | Registration holder | Myofunctional Research Co | 22 | 2015–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Myofunctional Research Co. Pty Ltd | 19 | 2022–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MYOFUNCTIONAL RESEARCH CO.Myofunctional Research Co. | 10 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Myofunctional Research Co. | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MYOFUNCTIONAL RESEARCH CO.MYOFUNCTIONAL RESEARCH CO., | 4 | 2008–2018 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | MyoFunctional Research Co. Pty Ltd | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MYOFUNCTIONAL RESEARCH CO. | 3 | 2007–2021 | Pure Global AI |
| China | NMPA | Registration holder | 曼奥芬肌功能研究有限公司Myofunctional Research Co. | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MYOFUNCTIONAL RESEARCH CO | 3 | — | 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 Myofunctional Research Co. Usa 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 |
|---|---|---|---|---|
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | BruxogardMyobraceMyoretainrMyotaleaTMDTMJ ApplianceTMJ-MBVTMJBDSTrainer | 2003 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Lingual Tubes BWS | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | — | 2018 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | BWS Band | 2024 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | MyoClean | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Myofunctional Research Co. Usa Inc. as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MYOFUNCTIONAL RESEARCH CO. USAFDA reg. 3005505603 | Rancho Cucamonga, CA, United States | Repacker / relabeler |
| MYOFUNCTIONAL RESEARCH CORP. PTY. LTD.FDA reg. 3006707038 | HELENSVALE Queensland, Australia | Foreign exporter, Manufacturer |
Other names on FDA records
MyoFunctional Research Co. Pty Ltd
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9002061). 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.