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DENTSCARE LTDA.

Brazil · Joinville

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, 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

14listed device types

Class I 7Class II 7Class III 0

plus 17 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

91registered devices

Class I 34Class II 57

98 including historic records

SASaudi ArabiaSFDA

20registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 4IIa 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

9active registrations

Class 2a 9

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 States17 registration records, 10 510(k), 0 PMA

Brazil91 confirmed, 0 excluded

Saudi Arabia20 confirmed, 0 excluded

Manufacturer names merged into this page: DENTSCARE LTDA · DENTSCARE LTDA.

FDA 510(k) clearances by year

42019 · K191306

32020 · K201707

12021 · K210231

22024 · K231859

FDA listed device types

showing 8 of 14

Applicator, Resin 1Wheel, Polishing Agent 1Retractor, All Types 1Dam, Rubber 1Drill, Dental, Intraoral 1Post, Root Canal 1Agent, Polishing, Abrasive, Oral Cavity 1Sealant, Pit And Fissure, And Conditioner 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231859	PrimmaArt	2024-11-26
US	K232994	Vittra APS Unique Flow	2024-10-18
US	K210231	Vittra APS Unique	2021-10-14
BR	80172310007	WHITENESS R. M.	Class I
BR	80172310006	FLUOR CARE	Class I
BR	80172310008	OPALLIS	Class II
SA	ME0000008269SFDAA00001	Condac Porcelana	—
SA	ME0000008269SFDAA00024	Whiteness RM	—

DENTSCARE LTDA.

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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