DI Scan

Basic Information

• Brand Name: DI Scan
• Primary DI: 04262352350035
• Version / Model: 04262352350035
• Catalog Number: S3806
• Company Name: Zetta25 AG
• Labeler DUNS: 480534923
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-21
• Public Version: 2
• Public Version Date: 2025-09-17
• Public Version Status: Update
• Public Device Record Key: f279c1a1-be9f-4b36-b8d3-57fad74a6784

Device Description

DI Scan

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOF	System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations	Dental	872.3661	2
NTK	Caries detector, laser light, transmission	Dental	872.1745	2
NBL	Laser, fluorescence caries detection	Dental	872.1745	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50484	CAD/CAM software	A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04262352350035	GS1