DEVICE: FONA STELLARIS (D7641000055741)

Device Identifier (DI) Information

FONA STELLARIS
100005574
In Commercial Distribution

SIRONA DENTAL, INC.
D7641000055741
HIBCC

1
078613913 *Terms of Use
FONA STELLARIS S0 SENSOR BASIC KIT, 2.7M/9FT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental digital imaging sensor, intraoral An 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.
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FDA Product Code

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Product Code Product Code Name
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
EHD Unit, X-Ray, Extraoral With Timer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

be7940b7-1430-4deb-a873-a00d407db43d
March 29, 2018
2
September 09, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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(877) 724-4254
customerserviceny@sirona.com
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