DEXIS HORIZONTAL HAND-HELD LL-UR

GUDID D090101351230

Dental Imaging Technologies Corporation

Dental x-ray film holder, reusable

• Primary Device ID: D090101351230
• NIH Device Record Key: e115bf2f-3a24-47b6-a583-1b7662513157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS HORIZONTAL HAND-HELD LL-UR
• Version Model Number: 1.013.5123
• Company DUNS: 800111106
• Company Name: Dental Imaging Technologies Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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	D090101351230 [Primary]

FDA Product Code

• EGZ: Holder, Film, X-Ray

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: 2022-12-14
• Device Publish Date: 2022-12-06

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• 00693856000302 - CS MODEL+: 2023-12-21 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
• D090800025720 - DEXIS Ti2 Sensor: 2023-12-20