DEXIS Ti2 Sensor Kit

GUDID D090800025750

DEXIS Ti2 Kit, EN FR-CA

Dental Imaging Technologies Corporation

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