uLab Systems uDesign FG0064

GUDID 00860002380032

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.

ULAB SYSTEMS, INC.

Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory Dental CAD/CAM system, laboratory
Primary Device ID00860002380032
NIH Device Record Key77e30334-fc5c-413e-8746-3a9dccdd2e02
Commercial Distribution StatusIn Commercial Distribution
Brand NameuLab Systems uDesign
Version Model NumberVersion 5.8
Catalog NumberFG0064
Company DUNS081092722
Company NameULAB SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]
GS100860002380032 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological
LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-09-16
Device Publish Date2020-07-14

On-Brand Devices [uLab Systems uDesign]

00860461001707The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by d
00008600023801The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by d
00000860002381The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by d
00860002380018The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by d
00860002380001The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by d
00860002380025The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by d
00860002380032The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by d

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