Identity
- Trade Name
- The TMJ System™ FDA UDI
- Generic Name
- Removable dental occlusal splint, preformed FDA UDI
- Model / Reference
- TMJ-MBV FDA UDI
Identifiers
- Catalog Number
- TMJ-MBV FDA UDI
- Primary DI / UDI-DI
- 19330944001732 FDA UDI
- 510(k) Number
- K924974 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Removable dental occlusal splint, preformed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Removable dental occlusal splint, preformed
The TMJ System™ by Myofunctional Research Corp. Pty. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Removable dental occlusal splint, preformed.
- Restoration, orthodontic — Modern Dental Laboratory (DG) Co., Ltd. · N
- Anti-snoring, splint — Modern Dental Laboratory (DG) Co., Ltd. · Class II
- Denture, restoration, orthodontic, anti-snoring, orthodontic — Modern Dental Laboratory (DG) Co., Ltd. · Class II
- Restoration, splint — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, splint — Modern Dental Laboratory (DG) Co., Ltd. · N
- PERF-GRID — Cynosure, LLC · Class I
- splint — Modern Dental Laboratory (DG) Co., Ltd. · N
- Pink EF Series, Splint — Modern Dental Laboratory (DG) Co., Ltd. · Class II
Cleared under the same submission
K924974 also covers:
- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd.
- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd.
- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd.
- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd.
- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd.
- The TMJ System™ — Myofunctional Research Corp. Pty. , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Myofunctional Research Corp. Pty. , Ltd.
Sources (1)
- FDA UDI 2607dd94-55f2-441f-afd9-638e8d10b00d 34 fields · synced Jun 6, 2026