DENT4YOU GMBH

Switzerland · Heerbrugg

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

20listed device types

Class I 13Class II 7Class III 0

plus 29 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 11Class II 8

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

13 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 2CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

28active ARTG entries

Class I 16IIa 8IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2a 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 States29 registration records, 4 510(k), 0 PMA

Brazil19 confirmed, 0 excluded

Manufacturer names merged into this page: DENT4YOU AG · DENT4YOU GMBH

FDA 510(k) clearances by year

12022 · K223142

22024 · K242360

12025 · K250969

FDA listed device types

showing 8 of 20

Absorber, Saliva, Paper 1Bur, Dental 1Handpiece, Air-Powered, Dental 1Frame, Rubber Dam 1Clamp, Rubber Dam 1Wheel, Polishing Agent 1Forceps, Rubber Dam Clamp 1Tray, Impression, Preformed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250969	JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST	2025-06-27
US	K242360	Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator	2024-11-15
US	K240801	BioSonic US200 Ultrasonic Scaler (60034537)	2024-07-01
BR	81118630025	HYSOLATE Flexi-Dam Non-Latex	Class I
BR	81118630026	Hysolate Clamps	Class I
BR	81118630027	Hysolate Wedjets Non Latex	Class I

DENT4YOU GMBH

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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