Primevision 3D 6758598

GUDID E27668234260

Primevision 3D

SIRONA Dental Systems GmbH

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device IDE27668234260
NIH Device Record Key3511f2a7-9429-47f2-8cb3-b119f889e33d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimevision 3D
Version Model Number6758598
Catalog Number6758598
Company DUNS340306351
Company NameSIRONA Dental Systems GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com
Phone+496251161670
Emailcontact@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE27668234260 [Primary]

FDA Product Code

OASX-ray, tomography, computed, dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-23
Device Publish Date2026-02-13

Devices Manufactured by SIRONA Dental Systems GmbH

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E27668303060 - Midwest Power Lux Motor2026-02-23 Midwest Power Lux Motor
E27665716860 - SiroLaser2025-09-11 single-use tips pack 250
E27662122080 - Motor BL implant2025-08-28 Motor BL implant
E27668534800 - CAD/CAM Software2025-08-27 CEREC SW 5.2 Full version, Primary, EDU
E2766802040 - Primescan 22025-05-26 Primescan 2
E27668020400 - Primescan 22025-05-26 Primescan 2

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