DEVICE: DEXIS Ti2 Sensor - R - S (D090800045720)

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Device Record History
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Device Identifier (DI) Information
DEXIS Ti2 Sensor - R - S
8.000.4572
In Commercial Distribution
8.000.4572
Dental Imaging Technologies Corporation
D090800045720
HIBCC

1
800111106 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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GMDN

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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.
Active false
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FDA Product Code

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Product Code Product Code Name
MUH System, X-Ray, Extraoral Source, Digital
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K233053 000
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Sterilization
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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
d631ca9f-e964-452d-a645-c14a4a0f53a2
April 09, 2026
1
April 01, 2026
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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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None
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Production Identifier(s) in UDI

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Yes
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Yes
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Customer Contact

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No Customer Contact currently defined
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