IS 3700 I/O 3D Scanner 5941307

GUDID 00693856000012

Dental Imaging Technologies Corporation

Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system

• Primary Device ID: 00693856000012
• NIH Device Record Key: 99862d38-a62e-4134-a41d-bfd908365ae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IS 3700 I/O 3D Scanner
• Version Model Number: 5941307
• Catalog Number: 5941307
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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
GS1	00693856000012 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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: 2022-09-14
• Device Publish Date: 2022-09-06

Devices Manufactured by Dental Imaging Technologies Corporation

• D090100879340 - DEXIS 10 (DEXIS Imaging Suite): 2024-03-20
• D090800025750 - DEXIS Ti2 Sensor Kit: 2024-01-31 DEXIS Ti2 Kit, EN FR-CA
• D090800025780 - DEXIS Ti2 Sensor Kit: 2024-01-31 DEXIS Ti2 Warranty Replacement NEW
• D090800025790 - DEXIS Ti2 Sensor Kit: 2024-01-31 Upgrade Kit, Sensor to Ti2
• D090800025800 - DEXIS Ti2 Sensor Kit: 2024-01-31 DEXIS Ti2 Warranty Replacement - R
• D090800025840 - DEXIS Ti2 Sensor Kit: 2024-01-31 Upgrade Kit, Platinum to Ti2
• 00693856000302 - CS MODEL+: 2023-12-21 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
• D090800025720 - DEXIS Ti2 Sensor: 2023-12-20