3shape Inc

FDA Filings

This page includes the latest FDA filings for 3shape Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

3shape Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• David Rothkopf
• 3SHAPE TRIOS A/S
• 3SHAPE Medical A/S

FDA Registration(s)

• Registration Number: 3010728558
• FEI Number: 3010728558
• Name: 3shape inc
• Owner & Operator: 3Shape A/S
• Contact Address: Holmens Kanal 7 ; Copenhagen K DK-84 Region Hovedstaden 1060 DK
• Official Correspondent:
  • David Rothkopf
  • 045-70-272620-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 10 Independence Blvd Ste 150 ; Warren, NJ 07059 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K191911 | PNN 3shape inc [3Shape A/S]	3Shape Splint Design	2020-01-23
PMN K171634 | PNN 3shape inc [3Shape A/S]	Ortho System	2018-01-24
PMN K151455 | PNP 3shape inc [3Shape A/S]	Abutment designer	2017-12-01
PMN K152086 | PNN 3shape inc [3Shape A/S]	3Shape Ortho System	2016-08-30
PMN K152086 | LLZ 3shape inc [3Shape A/S]	3Shape Ortho System	2016-08-30
PMN K141570 | LLZ 3shape inc [3Shape A/S]	Implant Studio	2014-12-22
OUG 3shape inc [3Shape A/S]	3Shape Communicate	2013-07-02
EJP 3shape inc [3Shape A/S]	3Shape Articulator	2012-03-04
NOF 3shape inc [3Shape A/S]	Trios Interoral Dental System	2007-12-20
NOF 3shape inc [3Shape A/S]	TRIOS Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	TRIOS Patient Monitoring	2007-12-20
NOF 3shape inc [3Shape A/S]	TRIOS 4	2007-12-20
NOF 3shape inc [3Shape A/S]	TRIOS 3 Wireles	2007-12-20
NOF 3shape inc [3Shape A/S]	Novux E4 Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	Novux E3 Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	Novux E2 Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	Novux E1 Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	Novux D850	2007-12-20
NOF 3shape inc [3Shape A/S]	Novux D750	2007-12-20
NOF 3shape inc [3Shape A/S]	Novux D2000	2007-12-20
NOF 3shape inc [3Shape A/S]	E4 Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	E3 Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	E2 Scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	E1 scanner	2007-12-20
NOF 3shape inc [3Shape A/S]	3Shape Dental System	2007-12-20
NOF 3shape inc [3Shape A/S]	3Shape Anatomy Design	2007-12-20
NOF 3shape inc [3Shape A/S]	3D scanner R900	2007-12-20
NOF 3shape inc [3Shape A/S]	3D scanner R710	2007-12-20
NOF 3shape inc [3Shape A/S]	3D scanner R500	2007-12-20
NOF 3shape inc [3Shape A/S]	3D scanner D900L	2007-12-20
NOF 3shape inc [3Shape A/S]	3D scanner D900	2007-12-20
NOF 3shape inc [3Shape A/S]	3D scanner D710	2007-12-20
NOF 3shape inc [3Shape A/S]	3D scanner D500	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner R850	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner R750	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner R700	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner R2000	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner R1000	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner D850	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner D810	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner D800	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner D750	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner D700	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner D2000	2007-12-20
NOF 3shape inc [3Shape A/S]	3D Scanner D1000	2007-12-20

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020071558118	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	FURNITURE	141 PCS