CS MODEL+ 594483

GUDID 00693856000302

LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

Dental Imaging Technologies Corporation

CAD/CAM software

• Primary Device ID: 00693856000302
• NIH Device Record Key: 552cc0b4-b33a-4e00-abef-60c029fa5739
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS MODEL+
• Version Model Number: 594483
• Catalog Number: 594483
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00693856000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193390

FDA Product Code

• PNN: Orthodontic Software

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: 2023-12-21
• Device Publish Date: 2023-12-13

Devices Manufactured by Dental Imaging Technologies Corporation

• D090101289030 - DEXcam4 HD: 2025-12-19
• 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