FDA Registration
Active
🇦🇺 Australia
SOMNOMED, LTD.
Reg #: 3005343849
·
FEI: 3005343849
·
Expires 2026
Products
5
Proprietary Names
19
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- SOMNOMED, LTD.
- Registration Number
- 3005343849
- FEI Number
- 3005343849
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LEVEL 3, 20 CLARKE ST.
- City
- CROWS NEST New South Wales
- Country
- AU
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
US Agent
- Business Name
- SomnoMed
- Contact Name
- Ioana Gabel
- Address
- 6513 Windcrest Dr Ste 100
- City
- Plano
- State
- TX
- ZIP
- 75024
- Country
- US
- [email protected]
- Phone
- 682 5572600
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 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2012-11-07 |
| Sleep Appliances With Patient Monitoring | PLC | Class 2 | Dental | No | 2015-10-26 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2015-11-05 |
Proprietary Names
SomnoDent Air+
Flex
SomnoDent Brux
DentiTrac
Herbst Advance Flex
Herbst Advance Classic
Herbst Shim Flex
Herbst Telescopic Flex
Herbst Shim Classic
Herbst Telescopic Classic
SomnoDent Herbst Advance Elite
Fusion Classic
Fusion Flex
SomnoDent Air
Classic Lingual-Less
Classic
SomGauge
SomnoDent AVANT
Virtus
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility