Identity
- Trade Name
- EMA (Elastic Mandibular Advancement appliance) FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- A removable intraoral device designed for the treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where advancement of the mandible and opening the bite can increase the patients air space. This is a reusable device. FDA UDI
- Model / Reference
- 3014680794 FDA UDI
- Description
- A removable intraoral device designed for the treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where advancement of the mandible and opening the bite can increase the patients air space. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810002220203 FDA UDI
- FDA Product Code
- LRK 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
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
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
EMA (Elastic Mandibular Advancement 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 002792b8-cb70-4c2c-a2c5-1b99d8ee4afd 33 fields · synced May 29, 2026