Data / Medical devices / United States / Myofunctional Research Co. Usa
Myofunctional Research Co. Usa: FDA-registered device maker in Rancho Cucamonga, CA, United States, 1 510(k) clearance
Myofunctional Research Co. Usa is registered with the FDA (registration 3005505603) in Rancho Cucamonga, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 23, 1993. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005505603
- Address
- 9267 Charles Smith Ave, Rancho Cucamonga, CA, United States, 91730
- Owner or operator
- MYOFUNCTIONAL RESEARCH CO USA INC (9002061)
- Roles
- Repackager or relabeler
- 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 | Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Repackager or relabeler | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2025 | 97890 | Class II | Ongoing | Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and my | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. | accessdata.fda.gov |
Compare with other makers
- All makers of Positioner, Tooth, Preformed
- All makers of Instruments, Dental Hand
- All makers of Cleanser, Denture, Over The Counter
- All makers of Tube, Orthodontic
- All makers of Band, Preformed, Orthodontic
Updated December 18, 2025. 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.