FDA.report

Orthophos S

Primary DI
E27666795960
Brand
Orthophos S
Company
SIRONA Dental Systems GmbH
Model
6679596
Device description
Orthophos S 2D individ.
Published
2019-07-10
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

Related Records

Contact Domains

Product Codes

CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E27666795960PrimaryHIBCC0

GMDN Terms

TermDefinition
Stationary panoramic/tomographic 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 used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
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 DIBrandCompanyProduct codePublished
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
E27668234260Primevision 3DSIRONA Dental Systems GmbHOAS2026-02-13
00990010312418DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312562DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312579DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312586DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312593DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312609DURAYBeyes Dental Canada IncOAS2025-12-15
08800003027026RCT700Ray Co., LtdOAS2025-12-01
08809244060335GenorayGENORAY CO., LTD.OAS2025-12-01
08809244060472GenorayGENORAY CO., LTD.OAS2025-12-01
06974566270167FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566270181FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271294FUSSENFussen Technology Co., Ltd.OAS2025-11-24
08800003027002RCT700Ray Co., LtdOAS2025-08-25
08800003027019RCT700Ray Co., LtdOAS2025-08-25
08800003027033RCT700Ray Co., LtdOAS2025-08-25
08800003027040RCT700Ray Co., LtdOAS2025-08-25
08800003027057RCT800Ray Co., LtdOAS2025-08-25
08800003027095RAYSCAN α-3DRay Co., LtdOAS2025-08-25
06430035875191ORTHOPANTOMOGRAPHâ„¢ OP 3DPaloDEx Group OyOAS2025-07-15
08809244060243GenorayGENORAY CO., LTD.OAS2025-05-02
08800000996042T2 PlusOsstem Implant Co.,Ltd.OAS2025-04-28
08800000996059T2 PlusOsstem Implant Co.,Ltd.OAS2025-04-28
08800003027064RCT600Ray Co., LtdOAS2025-04-14
08800003027071RCT600Ray Co., LtdOAS2025-04-14
08809244060250GenorayGENORAY CO., LTD.OAS2025-03-24
08809244060281GenorayGENORAY CO., LTD.OAS2025-03-24
06430035875184ORTHOPANTOMOGRAPHâ„¢ OP 3DPaloDEx Group OyOAS2025-03-11