Identity
- Trade Name
- Vivos DNA FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Upper mouth guard, migraine/tension headache, Jaw repositioning device FDA UDI
- Model / Reference
- 3014680794 FDA UDI
- Description
- Upper mouth guard, migraine/tension headache, Jaw repositioning device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810002220012 FDA UDI
- FDA Product Code
- OCO FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Vivos DNA by Johns Dental Laboratory — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Johns Dental Laboratory
Sources (1)
- FDA UDI 3354d9f5-038d-45d7-867b-28ea18a78a8f 34 fields · synced May 29, 2026