3Shape A/S

Denmark · Copenhagen

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 4Class III 0unclassified 1

plus 9 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

8 including historic records

TWTaiwanTFDA

7valid device licences

Class I 4Class II 3

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

6active ARTG entries

Class I 4IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 8 510(k), 0 PMA, 6 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: 3Shape A/S · 3SHAPE A/S

FDA 510(k) clearances by year

22016 · K151455

22017 · K163677

22018 · K180941

12019 · K191911

12020 · K200100

FDA listed device types

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1System, Image Processing, Radiological 1Dental Abutment Design Software For Dental Laboratory 1Orthodontic Software 1Mouthguard, Prescription 1

Market	Identifier	Name	Class / date
US	K200100	Abutment Design	2020-10-07
US	K191911	3Shape Splint Design	2019-11-27
US	K180941	Ortho System	2018-10-17
BR	81901710004	Software 3Shape Implant Studio	Class II

3Shape A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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