FDA.report

Aurora

Primary DI
D906000020
Brand
Aurora
Company
SODIUM SYSTEMS LLC
Model
S11685-12
Catalog number
00002
Device description
Aurora Size 2
Published
2018-10-25
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

Product Codes

CodeName
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications

CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions

SubmissionSupplement
K181636000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K181636000AuroraSodium Systems, LLC2018-07-20MUH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D906000020PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
060608848
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
D906000010AuroraS11684-12000012018-10-25

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