HomeSwedenDENTATUS AB

DENTATUS AB

Sweden · Spanga
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Israel — 6 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
16listed device types
Class I 14Class II 2Class III 0
plus 16 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 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
12 including historic records
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
pendingnot queried
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 States16 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: DENTATUS AB · Dentatus AB

Company information

Country
Sweden
City
Spanga

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 16
Retainer, Matrix 1Bur, Dental 1Instruments, Dental Hand 1Handpiece, Contra- And Right-Angle Attachment, Dental 1Accessories, Retractor, Dental 1Facebow 1Point, Abrasive 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10347940162Pontas Diamantadas Para Contra Ângulo PROFINClass I

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