DENTONA AG

Germany · Dortmund North Rhine-Westphalia

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 3 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 4Class II 0Class III 0unclassified 1

plus 5 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States5 registration records, 1 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: DENTONA AG

FDA 510(k) clearances by year

12023 · K222604

FDA listed device types

Mouthguard, Prescription 1Maintainer, Space Preformed, Orthodontic 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Teeth, Artificial, Backing And Facing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222604	dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S	2023-04-21
BR	80033549021	Discos Termoelásticos Optimill Dentona	Class II
BR	80033549025	Resinas de impressão 3D OptiPrint Dentona	Class II
BR	80033549026	Resinas de impressão 3D OptiPrint Dentona	Class II

DENTONA AG

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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