FDA.reportPublic FDA data

uLab Systems, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30171554773017155477uLab Systems, Inc1N2026-01-017005 Appling Farms Parkway Memphis TN US 38133

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2742972010113536K211510uLab Systems Dental Aligner KitNXC2022-02-24
2742971989172654K200772ULab Systems uDesign SoftwarePNN2020-06-23
2742971347743823K192596ULab Systems Dental Aligner KitNXC2020-02-11
2742971253153032K171295ULab Systems Treatment Planning SoftwarePNN2018-01-09
2742971668725199

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC22022-02-24
PNN22020-06-23