DEVICE: DEXIS IXS Size 2 Sensor Kit (D090101397200)
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Device Identifier (DI) Information
DEXIS IXS Size 2 Sensor Kit
1.013.9720
In Commercial Distribution
Dental Imaging Technologies Corporation
1.013.9720
In Commercial Distribution
Dental Imaging Technologies Corporation
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| No | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 44905 | 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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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K172918 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
bfe5a9ee-7ded-4ac6-b61e-0177e9b8c6dd
July 15, 2024
3
March 04, 2022
July 15, 2024
3
March 04, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined