ORTHOPHOS XG

GUDID E27663313130

TF XG Plus -> XG3D, 3D upgrade kit for a 2D device

SIRONA Dental Systems GmbH

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device IDE27663313130
NIH Device Record Key8538759e-ffdc-4b33-ba8b-05a1aee17a1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOPHOS XG
Version Model Number6331313
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4962511670
Emailcontact@dentsplysirona.com
Phone+4962511670
Emailcontact@dentsplysirona.com
Phone+4962511670
Emailcontact@dentsplysirona.com
Phone+4962511670
Emailcontact@dentsplysirona.com
Phone+4962511670
Emailcontact@dentsplysirona.com
Phone+4962511670
Emailcontact@dentsplysirona.com
Phone+4962511670
Emailcontact@dentsplysirona.com
Phone+4962511670
Emailcontact@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE27663313130 [Primary]

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-29
Device Publish Date2016-09-10

On-Brand Devices [ORTHOPHOS XG]

E27663000290ORTHOPHOS XG 3D CEPH
E27664316670ORTHOPHOS XG 3D Ceph
E27664316590ORTHOPHOS XG 3D
E27663688360TF XG plus TSA/Ceph -> XG3D, 3D upgrade kit for a 2D device
E276636264903D ready --> 3D, 3D upgrade kit for a 2D device
E27663313210TF XG5 -> XG3D, 3D upgrade kit for a 2D device
E27663313130TF XG Plus -> XG3D, 3D upgrade kit for a 2D device
E27663000110ORTHOPHOS XG 3D
E27662812520ORTHOPHOS XG 3D ready
E27662812450ORTHOPHOS XG 3D ready Ceph
E27662812370ORTHOPHOS XG 5 Ceph/ XG 5DS Ceph
E27662812290ORTHOPHOS XG 5 / XG 5DS
E27662372390ORTHOPHOS XG 3
E27660055860ORTHOPHOS XG 3
E27659934020Cephalometer retrofit left / right
E27659933940ORTHOPHOS XG 5 / XG 5DS
E27659933860ORTHOPHOS XG 5 Ceph/XG 5DS Ceph
E27659638680ORTHOPHOS XG 3D ready Ceph
E27659638500ORTHOPHOS XG 3D ready

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.