uLab Systems uDesign

Basic Information

• Brand Name: uLab Systems uDesign
• Primary DI: 00860002380001
• Version / Model: Version 5
• Catalog Number: FG0064
• Company Name: Ulab Systems, Inc.
• Labeler DUNS: 081092722
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-18
• Public Version: 6
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 67ef0880-1b33-4bb5-be9e-16979f175b0b
• Distribution End Date: 2020-01-31

Device Description

The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers

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: Yes
• Has Serial Number: No
• 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
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2
PNN	Orthodontic Software	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34713	Dental milling system, CAD/CAM, laboratory	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for production of the actual device(s) for delivery and final fitting to the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002380001	GS1