DEXIS Ti2 Sensor Kit

GUDID D090800025750

DEXIS Ti2 Kit, EN FR-CA

Dental Imaging Technologies Corporation

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: D090800025750
• NIH Device Record Key: 36ee9684-66d9-43d5-98be-91bdb0fcac89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS Ti2 Sensor Kit
• Version Model Number: 8.000.2575
• 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: true
• 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	D090800025750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233053

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: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [DEXIS Ti2 Sensor Kit]

• D090800025840: Upgrade Kit, Platinum to Ti2
• D090800025800: DEXIS Ti2 Warranty Replacement - R
• D090800025790: Upgrade Kit, Sensor to Ti2
• D090800025780: DEXIS Ti2 Warranty Replacement NEW
• D090800025750: DEXIS Ti2 Kit, EN FR-CA