3shape A S

FDA Filings

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

FDA Registration(s)
Registration Number3010700948
FEI Number3010700948
Name3SHAPE Medical A/S
Owner & Operator3Shape A/S
Contact AddressHolmens Kanal 7
Copenhagen K DK-84 Region Hovedstaden 1060 DK
Official Correspondent
  • David Rothkopf
  • 045-70-272620-x
US Agent
Importing Logistics Registration
Importer3Shape Inc.
Address571 Central Ave Suite 109
New Providence, NJ 07974 UNITED STATES
Importer Typesales office
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressHolmens Kanal 7
Copenhagen K Region Hovedstaden, 1060 DK
Establishment TypeManufacture Medical Device



Registration Number3005940400
FEI Number3005940400
NameDavid Rothkopf
Owner & Operator3Shape A/S
Contact AddressHolmens Kanal 7
Copenhagen K DK-84 Region Hovedstaden 1060 DK
Official Correspondent
  • David Rothkopf
  • 045-70-272620-x
US Agent
Importing Logistics Registration
Importer3Shape Inc.
Address571 Central Ave Suite 109
New Providence, NJ 07974 UNITED STATES
Importer Typesales office
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



Registration Number3015193486
FEI Number3015193486
Name3Shape Manufacturing US LLC
Owner & Operator3Shape A/S
Contact AddressHolmens Kanal 7
Copenhagen K DK-84 Region Hovedstaden 1060 DK
Official Correspondent
  • David Rothkopf
  • 045-70-272620-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3921 South Miami Boulevard
Durham, NC 27703 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3015172511
FEI Number3015172511
NameDavid Rothkopf
Owner & Operator3Shape A/S
Contact AddressHolmens Kanal 7
Copenhagen K DK-84 Region Hovedstaden 1060 DK
Official Correspondent
  • David Rothkopf
  • 045-70-272620-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 Homer Ave
Ashland, MA 01721 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3010728558
FEI Number3010728558
Name3shape inc
Owner & Operator3Shape A/S
Contact AddressHolmens Kanal 7
Copenhagen K DK-84 Region Hovedstaden 1060 DK
Official Correspondent
  • David Rothkopf
  • 045-70-272620-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address10 Independence Blvd Ste 150
Warren, NJ 07059 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
3Shape A/S
Abutment Design2020-10-07
David Rothkopf [3Shape A/S]
3Shape Splint Design2020-01-23
3shape inc [3Shape A/S]
3Shape Splint Design2020-01-23
David Rothkopf [3Shape A/S]
Ortho System2019-12-31
David Rothkopf [3Shape A/S]
3Shape Ortho System Mouthguard2019-12-31
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape scan bodies 2019-12-23
3shape A/S
3Shape Scan Bodies 2019-12-23
3shape A/S
3Shape Scan Bodies 2019-12-23
3Shape A/S
3Shape Splint Design2019-11-27
3shape A/S
Lab Scanner 2019-07-05
3shape A/S
Lab Scanner 2019-07-04
3Shape A/S
Ortho System2018-10-17
3shape A/S
3Shape Ortho System 2018-07-06
3shape A/S
Ortho System 2018-07-06
3shape A/S
3Shape 2018-06-21
3shape A/S
3Shape 2018-06-21
3shape A/S
3Shape 2018-06-21
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
3Shape Scan Bodies 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-06-14
3shape A/S
Lab Scanner 2018-04-13
3shape A/S
Lab Scanner 2018-04-13
3shape A/S
Lab Scanner 2018-04-13
3shape A/S
3Shape Scan Posts 2018-03-29
3shape A/S
3Shape Scan Posts 2018-03-29
3shape A/S
3Shape Scan Posts 2018-03-29
3shape A/S
3Shape Scan Posts 2018-03-29
3shape A/S
3Shape Scan Posts 2018-03-29
3shape A/S
3Shape Scan Posts 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
3shape A/S
Lab Scanner 2018-03-29
David Rothkopf [3Shape A/S]
Ortho System2018-01-24
3shape inc [3Shape A/S]
Ortho System2018-01-24
3Shape A/S
Ortho System2018-01-17
David Rothkopf [3Shape A/S]
Abutment designer2017-12-01
3shape inc [3Shape A/S]
Abutment designer2017-12-01
3Shape A/S
Ortho System2017-04-20
3Shape A/S
Ortho System2017-04-19
3Shape A/S
3Shape Abutment Designer Software2016-09-06
David Rothkopf [3Shape A/S]
3Shape Ortho System2016-08-30
3shape inc [3Shape A/S]
3Shape Ortho System2016-08-30
David Rothkopf [3Shape A/S]
3Shape Ortho System2016-08-30
3shape inc [3Shape A/S]
3Shape Ortho System2016-08-30
3Shape A/S
3Shape Ortho System2016-04-28
3shape inc [3Shape A/S]
Implant Studio2014-12-22
3SHAPE Medical A/S [3Shape A/S]
Implant Studio2014-12-22
David Rothkopf [3Shape A/S]
3Shape Communicate2013-07-02
3shape inc [3Shape A/S]
3Shape Communicate2013-07-02
David Rothkopf [3Shape A/S]
3Shape Articulator2012-03-04
3shape inc [3Shape A/S]
3Shape Articulator2012-03-04
David Rothkopf [3Shape A/S]
Trios Interoral Dental System2007-12-20
David Rothkopf [3Shape A/S]
Trios Interoral Dental System2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Scanner2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Scanner2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Patient Monitoring2007-12-20
David Rothkopf [3Shape A/S]
TRIOS Patient Monitoring2007-12-20
David Rothkopf [3Shape A/S]
TRIOS 42007-12-20
David Rothkopf [3Shape A/S]
TRIOS 42007-12-20
David Rothkopf [3Shape A/S]
TRIOS 3 Wireles2007-12-20
David Rothkopf [3Shape A/S]
TRIOS 3 Wireles2007-12-20
David Rothkopf [3Shape A/S]
Novux E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E1 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux E1 Scanner2007-12-20
David Rothkopf [3Shape A/S]
Novux D8502007-12-20
David Rothkopf [3Shape A/S]
Novux D8502007-12-20
David Rothkopf [3Shape A/S]
Novux D7502007-12-20
David Rothkopf [3Shape A/S]
Novux D7502007-12-20
David Rothkopf [3Shape A/S]
Novux D20002007-12-20
David Rothkopf [3Shape A/S]
Novux D20002007-12-20
David Rothkopf [3Shape A/S]
E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E4 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E3 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E2 Scanner2007-12-20
David Rothkopf [3Shape A/S]
E1 scanner2007-12-20
David Rothkopf [3Shape A/S]
E1 scanner2007-12-20
David Rothkopf [3Shape A/S]
3Shape Dental System2007-12-20
David Rothkopf [3Shape A/S]
3Shape Dental System2007-12-20
David Rothkopf [3Shape A/S]
3Shape Anatomy Design2007-12-20
David Rothkopf [3Shape A/S]
3Shape Anatomy Design2007-12-20
David Rothkopf [3Shape A/S]
3D scanner R9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner R9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner R7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner R7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner R5002007-12-20
David Rothkopf [3Shape A/S]
3D scanner R5002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D900L2007-12-20
David Rothkopf [3Shape A/S]
3D scanner D900L2007-12-20
David Rothkopf [3Shape A/S]
3D scanner D9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D9002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner D7102007-12-20
David Rothkopf [3Shape A/S]
3D scanner D5002007-12-20
David Rothkopf [3Shape A/S]
3D scanner D5002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R10002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner R10002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8102007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8102007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D8002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7502007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D7002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D20002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D10002007-12-20
David Rothkopf [3Shape A/S]
3D Scanner D10002007-12-20
3shape inc [3Shape A/S]
Trios Interoral Dental System2007-12-20
3shape inc [3Shape A/S]
TRIOS Scanner2007-12-20
3shape inc [3Shape A/S]
TRIOS Patient Monitoring2007-12-20
3shape inc [3Shape A/S]
TRIOS 42007-12-20
3shape inc [3Shape A/S]
TRIOS 3 Wireles2007-12-20
3shape inc [3Shape A/S]
Novux E4 Scanner2007-12-20
3shape inc [3Shape A/S]
Novux E3 Scanner2007-12-20
3shape inc [3Shape A/S]
Novux E2 Scanner2007-12-20
3shape inc [3Shape A/S]
Novux E1 Scanner2007-12-20
3shape inc [3Shape A/S]
Novux D8502007-12-20
3shape inc [3Shape A/S]
Novux D7502007-12-20
3shape inc [3Shape A/S]
Novux D20002007-12-20
3shape inc [3Shape A/S]
E4 Scanner2007-12-20
3shape inc [3Shape A/S]
E3 Scanner2007-12-20
3shape inc [3Shape A/S]
E2 Scanner2007-12-20
3shape inc [3Shape A/S]
E1 scanner2007-12-20
3shape inc [3Shape A/S]
3Shape Dental System2007-12-20
3shape inc [3Shape A/S]
3Shape Anatomy Design2007-12-20
3shape inc [3Shape A/S]
3D scanner R9002007-12-20
3shape inc [3Shape A/S]
3D scanner R7102007-12-20
3shape inc [3Shape A/S]
3D scanner R5002007-12-20
3shape inc [3Shape A/S]
3D scanner D900L2007-12-20
3shape inc [3Shape A/S]
3D scanner D9002007-12-20
3shape inc [3Shape A/S]
3D scanner D7102007-12-20
3shape inc [3Shape A/S]
3D scanner D5002007-12-20
3shape inc [3Shape A/S]
3D Scanner R8502007-12-20
3shape inc [3Shape A/S]
3D Scanner R7502007-12-20
3shape inc [3Shape A/S]
3D Scanner R7002007-12-20
3shape inc [3Shape A/S]
3D Scanner R20002007-12-20
3shape inc [3Shape A/S]
3D Scanner R10002007-12-20
3shape inc [3Shape A/S]
3D Scanner D8502007-12-20
3shape inc [3Shape A/S]
3D Scanner D8102007-12-20
3shape inc [3Shape A/S]
3D Scanner D8002007-12-20
3shape inc [3Shape A/S]
3D Scanner D7502007-12-20
3shape inc [3Shape A/S]
3D Scanner D7002007-12-20
3shape inc [3Shape A/S]
3D Scanner D20002007-12-20
3shape inc [3Shape A/S]
3D Scanner D10002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Trios Interoral Dental System2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
TRIOS Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
TRIOS Patient Monitoring2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
TRIOS 42007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
TRIOS 3 Wireles2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Novux E4 Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Novux E3 Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Novux E2 Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Novux E1 Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Novux D8502007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Novux D7502007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
Novux D20002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
E4 Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
E3 Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
E2 Scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
E1 scanner2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3Shape Dental System2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3Shape Anatomy Design2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D scanner R9002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D scanner R7102007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D scanner R5002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D scanner D900L2007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D scanner D9002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D scanner D7102007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D scanner D5002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner R8502007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner R7502007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner R7002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner R20002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner R10002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner D8502007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner D8102007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner D8002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner D7502007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner D7002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner D20002007-12-20
3Shape Manufacturing US LLC [3Shape A/S]
3D Scanner D10002007-12-20

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NCAGE CodeR63963SHAPE A/S
CAGE CodeR63963SHAPE A/S

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