FDA.report

Orthophos E

Primary DI
E27667074700
Brand
Orthophos E
Company
SIRONA Dental Systems GmbH
Model
6707470
Device description
Orthophos E
Published
2021-09-08
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
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications

CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E27667074700PrimaryHIBCC0

GMDN Terms

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

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

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