The following data is part of a premarket notification filed by Myofunctional Research Corp. Pty. Ltd. with the FDA for The Tmj Appliance.
| Device ID | K924974 |
| 510k Number | K924974 |
| Device Name: | THE TMJ APPLIANCE |
| Classification | Positioner, Tooth, Preformed |
| Applicant | MYOFUNCTIONAL RESEARCH CORP. PTY. LTD. P.O. BOX 14 Helensvale, Queensland, AU 4212 |
| Contact | Chris Farrell |
| Correspondent | Chris Farrell MYOFUNCTIONAL RESEARCH CORP. PTY. LTD. P.O. BOX 14 Helensvale, Queensland, AU 4212 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19330944001749 | K924974 | 000 |
| 19330944001725 | K924974 | 000 |
| 19330944001701 | K924974 | 000 |
| 19330944001688 | K924974 | 000 |
| 19330944001718 | K924974 | 000 |
| 19330944001695 | K924974 | 000 |
| 19330944001732 | K924974 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THE TMJ APPLIANCE 88935150 not registered Live/Pending |
Myofunctional Research Corporation Pty.Limited 2020-05-27 |