FDA.reportPublic FDA data

3shape inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
301072855830107285583shape inc1Y2026-01-01430 Mountain Avenue, Suite 205 New Providence NJ US 07974

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1652361792508803K242103TRIOS Ready TipNBL2025-04-04
1652361934701753K221249L1P-1F (TRIOS 5)NBL2022-09-16
1652361292601681K2022563Shape Implant StudioLLZ2020-09-09
1652361609427151K200100Abutment DesignPNP2020-10-07
1652361882360268K1919113Shape Splint DesignPNN2019-11-27
1652361729276841K171634Ortho SystemPNN2018-01-17
1652361339227374K1520863Shape Ortho SystemPNN2016-04-28
1652361725480996K1514553Shape Abutment Designer SoftwarePNP2016-09-06
1652362001228329K141570IMPLANT STUDIOLLZ2014-10-31
1652361035002055
1652361361505827
1652361558101016

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PNN32019-11-27
NBL22025-04-04
PNP22020-10-07
LLZ22020-09-09