Data / Medical devices / Australia / Myofunctional Research Corp. Pty. Ltd.
Myofunctional Research Corp. Pty. Ltd.: FDA-registered device maker in HELENSVALE Queensland, Australia, 1 510(k) clearance
Myofunctional Research Corp. Pty. Ltd. is registered with the FDA (registration 3006707038) in HELENSVALE Queensland, Australia. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 23, 1993. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006707038
- Address
- 44 Siganto Drive, HELENSVALE Queensland, Australia, 4212
- Owner or operator
- MYOFUNCTIONAL RESEARCH CO USA INC (9002061)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 3, 2003
- Registered through
- 2027
- Brand names listed
- BWS Band, Bruxogard, Lingual Tubes BWS, MyoClean, Myobrace, Myoretainr, Myotalea, TMD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Preformed, Orthodontic | ECM | 1 | Exporter to the US | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Exporter to the US | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Exporter to the US | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| June 23, 1993 | K924974 | THE TMJ APPLIANCE | KMY | Substantially Equivalent for Some Indications | Myofunctional Research Corp. Pty. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleanser, Denture, Over The Counter
- All makers of Positioner, Tooth, Preformed
- All makers of Instruments, Dental Hand
- All makers of Band, Preformed, Orthodontic
- All makers of Tube, Orthodontic
Updated June 23, 1993. 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.