uLab Systems uDesign

FDA UDI

Class II (US FDA UDI)

by uLab Systems, Inc

Identity

Trade Name: uLab Systems uDesign FDA UDI
Generic Name: Dental milling system, CAD/CAM, laboratory FDA UDI
Device Name: 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. FDA UDI
Model / Reference: Version 5.8 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: FG0064 FDA UDI
Primary DI / UDI-DI: 00860002380032 FDA UDI
FDA Product Code: LLZ FDA UDI
PNN FDA UDI
GMDN Term: Dental milling system, CAD/CAM, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
872.5470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Dental milling system, CAD/CAM, laboratory

uLab Systems uDesign by uLab Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: uLab Systems, Inc

Sources (1)

FDA UDI 77e30334-fc5c-413e-8746-3a9dccdd2e02 34 fields · synced Jun 8, 2026