← Back to catalogue

VisionX

FDA UDI

Class II (US FDA UDI)

by Dürr Dental Se

Identity

Trade Name
VisionX FDA UDI
Generic Name
General-purpose dental x-ray system application software FDA UDI
Device Name
VisionX version 3.0.x FDA UDI
Model / Reference
E7300 FDA UDI
Description
VisionX version 3.0.x FDA UDI

Identifiers

Primary DI / UDI-DI
E247E7300A10 FDA UDI
510(k) Number
K213326 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
General-purpose dental x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

Yes

FDA UDI

Category: General-purpose dental x-ray system application software

VisionX by Dürr Dental Se — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose dental x-ray system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dürr Dental Se

Sources (1)

  • FDA UDI 130323f1-341e-47c3-870a-2684dfdb2ea4 34 fields · synced Jun 8, 2026