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DTX Studio™ Core

FDA UDI

Class I (US FDA UDI)

by Nobel Biocare AG

Identity

Trade Name
DTX Studio™ Core FDA UDI
Generic Name
Radiology picture archiving and communication system digital archive device FDA UDI
Device Name
DTX Studio Core 3.13 for Windows 64-bit FDA UDI
Model / Reference
3.13 FDA UDI
Description
DTX Studio Core 3.13 for Windows 64-bit FDA UDI

Identifiers

Catalog Number
300547 FDA UDI
Primary DI / UDI-DI
07332747197136 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Radiology picture archiving and communication system digital archive device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiology picture archiving and communication system digital archive device

DTX Studio™ Core by Nobel Biocare AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system digital archive device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nobel Biocare AG

Sources (1)

  • FDA UDI 068b1072-b83a-49f0-8087-32e79f7796e1 35 fields · synced Jun 8, 2026