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Videa Caries Assist

FDA UDI

Class II (US FDA UDI)

by Videahealth, Inc.

Identity

Trade Name
Videa Caries Assist FDA UDI
Generic Name
Dental x-ray image interpretive software FDA UDI
Device Name
Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older. FDA UDI
Model / Reference
VCA01B FDA UDI
Description
Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions. Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older. FDA UDI

Identifiers

Primary DI / UDI-DI
00196852162192 FDA UDI
510(k) Number
K213795 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
Not 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

Videa Caries Assist by Videahealth, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Videahealth, Inc.

Sources (1)

  • FDA UDI fc950bef-2d02-49c4-8e67-afd4cef302eb 36 fields · synced Jun 1, 2026