Identity
- Trade Name
- Videa Dental Assist FDA UDI
- Generic Name
- Dental x-ray image interpretive software FDA UDI
- Device Name
- Update: Now commercialized under the brand name 'Videa Dental AI'. Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older. FDA UDI
- Model / Reference
- VDA01BPN FDA UDI
- Description
- Update: Now commercialized under the brand name 'Videa Dental AI'. Videa Dental AI is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize suspect dental finding, historical treatment and normal anatomy features. Videa Dental Assist is indicated for the review of bitewing, periapical, and panoramic radiographs acquired from patients aged 3 years or older. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009836822 FDA UDI
- 510(k) Number
- K232384 FDA UDI
- FDA Product Code
- MYN FDA UDI
- GMDN Term
- Dental x-ray image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2070 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental x-ray image interpretive software
Videa Dental Assist by Videahealth, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Videahealth, Inc.
Sources (1)
- FDA UDI 2a281813-a611-43db-8788-73c708a4b826 35 fields · synced May 31, 2026