FDA.reportPublic FDA data

Orthophos E

Primary DI
E27667084030
Brand
Orthophos E
Company
SIRONA Dental Systems GmbH
Model
6708403
Device description
Orthophos E
Published
2019-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27667084030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4962511670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E27668665320Midwest IMPLANT 20:168665322026-02-19
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E27668234260Primevision 3D675859867585982026-02-13
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27665716860SiroLaser65716862025-09-03
E27662122080Motor BL implant62122082025-08-20
E27668534800CAD/CAM Software68534802025-08-19
E2766802040Primescan 2680204068020402025-05-16
E27668020400Primescan 2680204068020402025-05-16
E27668053650Primescan 2 Multiuse Sleeve680536568053652025-05-06
E27668325750TiBase683257568325752025-05-06
E27668325830TiBase683258368325832025-05-06
E27668326090TiBase683260968326092025-05-06
E27668326170TiBase683261768326172025-05-06
E27668326250TiBase683262568326252025-05-06
E27668326330TiBase683263368326332025-05-06
E27668326580TiBase683265868326582025-05-06
E27668326660TiBase683266668326662025-05-06
E27668004570Primescan 2 Cart680045768004572025-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800018424704XERO-alphaDRTECH CorporationEHD2026-03-17
08809244060649GenorayGENORAY CO., LTD.EHD2025-12-01
08809244060656GenorayGENORAY CO., LTD.EHD2025-12-01
08809244060663GenorayGENORAY CO., LTD.EHD2025-12-01
08809244060670GenorayGENORAY CO., LTD.EHD2025-12-01
00860014827303LifeRayLucas Lifecare, LLCEHD2025-10-21
03760262653006Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653013Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653020Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653044Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653051Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653068Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653075Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653327Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653334Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653372Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653389Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653396Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653402Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653419Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262653426Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-05
03760262652993Owandy-RX DCOWANDY RADIOLOGYEHD2025-09-04
D804592151000x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151010x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151020x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151070x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151080x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151090x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151100x-mind dcDE GÖTZEN SRLEHD2025-09-04
D804592151110x-mind dcDE GÖTZEN SRLEHD2025-09-04