Identity
- Trade Name
- Ora-GUARD FDA UDI
- Generic Name
- Removable dental occlusal splint, customizable FDA UDI
- Device Name
- Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816161015131 FDA UDI
- FDA Product Code
- OBR FDA UDI
- GMDN Term
- Removable dental occlusal splint, customizable 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
No
FDA UDI
Over-the-Counter
Yes
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: Removable dental occlusal splint, customizable
Ora-GUARD by Doc Brands, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Removable dental occlusal splint, customizable.
- SOVA — AKERVALL TECHNOLOGIES · U
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
- Doc Brands, Inc.
Sources (1)
- FDA UDI 6a947f81-c112-4301-ab0e-8d45f4f55db7 34 fields · synced May 31, 2026