Identity
- Trade Name
- Herbst FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- A removable intraoral device intended for the reduction of mild to moderate obstructive sleep apnea and snoring. This is a reusable device. FDA UDI
- Model / Reference
- 3014680794 FDA UDI
- Description
- A removable intraoral device intended for the reduction of mild to moderate obstructive sleep apnea and snoring. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810002220272 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
- Not 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
Herbst by Johns Dental Laboratory — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 6614cb6f-a3cb-4814-8f57-36251b610e48 34 fields · synced Jun 1, 2026