Identity
- Trade Name
- mmRNA appliance FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. FDA UDI
- Model / Reference
- 3014680794 FDA UDI
- Description
- The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810002220111 FDA UDI
- FDA Product Code
- LRK FDA UDILQZ FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
mmRNA appliance by Johns Dental Laboratory — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Johns Dental Laboratory
Sources (1)
- FDA UDI 883827ef-fb0d-492d-8a88-0fc5c8548b72 33 fields · synced Jun 8, 2026