uLab Systems Dental Aligner

GUDID 00860002380056

ULAB SYSTEMS, INC.

Dental CAD/CAM system, laboratory
Primary Device ID00860002380056
NIH Device Record Key167df33d-2aee-4d86-9ef3-ee8a2d7baaa2
Commercial Distribution StatusIn Commercial Distribution
Brand NameuLab Systems Dental Aligner
Version Model NumberFG0094
Company DUNS081092722
Company NameULAB SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002380056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-28
Device Publish Date2020-07-20

On-Brand Devices [uLab Systems Dental Aligner]

00860002380056FG0094
00860002380063FG0094 Rev. D
00860002380094The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-

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