FDA.reportPublic FDA data

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#

Implant Studio - 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dentalimplantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operativesimulation and evaluation of patient anatomy and dental implant placement.Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3Dmanufacturing systems.

3shape A/S

2023-07-27

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