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Cdr Dicom

FDA UDI

Class II (US FDA UDI)

by Sirona Dental, Inc.

Identity

Trade Name
CDR DICOM FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation application software FDA UDI
Device Name
CDR DICOM 5.0 FOR WINDOWS SOFTWARE FDA UDI
Model / Reference
B1030191 FDA UDI
Description
CDR DICOM 5.0 FOR WINDOWS SOFTWARE FDA UDI

Identifiers

Primary DI / UDI-DI
D764B10301910 FDA UDI
FDA Product Code
EAP FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1810 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation application software

Cdr Dicom by Sirona Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sirona Dental, Inc.

Sources (1)

  • FDA UDI 952027cc-1c4d-4fd2-9f53-e86aefb113b7 34 fields · synced May 31, 2026