IS 3800 I/O 3D SCANNER 5943725

GUDID 00693856000043

IS 3800

Dental Imaging Technologies Corporation

Intraoral optical scanning system

• Primary Device ID: 00693856000043
• NIH Device Record Key: 86115946-6057-4620-a906-785098471841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IS 3800 I/O 3D SCANNER
• Version Model Number: 5943725
• Catalog Number: 5943725
• 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	00693856000043 [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: 2023-06-02
• Device Publish Date: 2023-05-25

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