DEXIS Titanium Intraoral X-Ray Sensor

GUDID D090101261800

Dental Imaging Technologies Corporation

Dental digital imaging sensor, intraoral

• Primary Device ID: D090101261800
• NIH Device Record Key: 560b1776-571e-4294-9b47-2c216c8aebe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS Titanium Intraoral X-Ray Sensor
• Version Model Number: 1.012.6180
• Company DUNS: 800111106
• Company Name: Dental Imaging Technologies Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D090101261800 [Primary]
HIBCC	EKAV101261800 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172918

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-14
• Device Publish Date: 2022-03-04

Devices Manufactured by Dental Imaging Technologies Corporation

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• 00693856000159 - Assembly-IS 3600 SIDE TIP: 2025-12-12
• 00693856000173 - Assembly-IS 3600 POSTERIOR TIP: 2025-12-12
• 00693856000197 - Assembly-IS 3700 NORMAL TIP: 2025-12-12
• 00693856000203 - Assembly-IS 3700 SIDE TIP: 2025-12-12
• 00693856000227 - Assembly-IS 3700 POSTERIOR TIP: 2025-12-12
• 00693856000258 - Assembly-IS 3800 NORMAL TIP: 2025-12-12
• 00693856000272 - Assembly-IS 3800 SIDE TIP: 2025-12-12