3SHAPE TRIOS A/S

Matched from indexed company URL: 3shape inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
300956001330095600133SHAPE TRIOS A/S1N2026-01-01Holmens Kanal 7 copenhagen Hovedstaden DK 1060
301072855830107285583shape inc1Y2026-01-01430 Mountain Avenue, Suite 205 New Providence NJ US 07974
301517251130151725113Shape Poland Sp. zo.o1N2026-01-01Poludniowa 27c Szczecin Zachodniopomorskie PL 71001
301519348630151934863Shape Inc.1N2026-01-012800 Perimeter Park Drive Suite E Morrisville NC US 27560
301070094830107009483SHAPE Medical A/S1N2020-04-25Holmens Kanal 7 Copenhagen K Region Hovedstaden DK 1060

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05902729750356Lab Scanner - Digital impression lab scanner for CAD/CAM+4570272620support@3shape.com
05902729750417Lab Scanner - Digital impression lab scanner for CAD/CAM+4570272620support@3shape.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1397831185670927K260082TRIOS Dx (R1)SHQ2026-04-10
1397831669311480K242103TRIOS Ready TipNBL2025-04-04
1652361792508803K242103TRIOS Ready TipNBL2025-04-04
1397831567106466K221249L1P-1F (TRIOS 5)NBL2022-09-16
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
1677532001228329K141570IMPLANT STUDIOLLZ2014-10-31
1652361035002055
2267291035002055
2267301035002055
1397831278257567
1652361361505827
1652361558101016
1397831809842843
1397831281181960
2267291554105364
2267291792508803
2267301792508803
2267291934701753
2267301934701753

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBL42025-04-04
LLZ32020-09-09
PNN32019-11-27
PNP22020-10-07
SHQ12026-04-10

PMN#

GUDID#

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