FDA Registration
Active
🇺🇸 United States
SOMNOMED INC.
Reg #: 3005598536
·
FEI: 3005598536
·
Expires 2026
Products
7
Proprietary Names
21
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- SOMNOMED INC.
- Registration Number
- 3005598536
- FEI Number
- 3005598536
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6513 Windcrest Dr Ste 100
- City
- Plano
- State
- TX
- ZIP
- 75024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073004
Owner / Operator
- Firm Name
- SOMNOMED INC.
- Operator Number
- 9071127
- Address
- 6513 Windcrest Drive, Suite #100
- City
- Plano
- State
- TX
- Postal Code
- 75024
- Country
- US
- Correspondent
- Mary Kennell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2011-07-28 |
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2011-07-28 |
| Sleep Appliances With Patient Monitoring | PLC | Class 2 | Dental | No | 2019-07-15 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2015-11-05 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2015-11-11 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2012-11-07 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2014-11-06 |
Proprietary Names
SomnoDent Air+
Flex
Herbst Advance Flex
Herbst Advance Classic
Herbst Shim Flex
Herbst Telescopic Flex
Herbst Shim Classic
Herbst Telescopic Classic
SomnoDent Herbst Advance Elite
SomnoDent AVANT
SomGauge
Fusion Classic
Fusion Flex
Virtus
Morning Repositioner
SomnoDent Air
Classic Lingual-Less
Classic
SomnoDent Brux
SomTabs
DentiTrac
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device