Identity
- Trade Name
- SomnoDent Brux FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- Oral Device To Prevent Damage Due To Bruxism. FDA UDI
- Model / Reference
- B1000-1012 FDA UDI
- Description
- Oral Device To Prevent Damage Due To Bruxism. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851826007151 FDA UDI
- 510(k) Number
- K102909 FDA UDI
- FDA Product Code
- MQC FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
SomnoDent Brux by Somnomed Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 U | Pending data |
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Manufacturer
- Manufacturer
- Somnomed Inc.
Sources (1)
- FDA UDI d336992e-c504-4be2-abcd-a473393595a8 35 fields · synced May 31, 2026