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COSMEDENT, INC.

USA · Chicago

✓ Record-verifiedregistrations found in 6 markets

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

24listed device types

Class I 14Class II 10Class III 0

plus 53 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 4Class 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

5 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States53 registration records, 28 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: COSMEDENT, INC. · COSMEDENT INC.

FDA 510(k) clearances by year

21986

11987

11989

11990

11992

11993

41998

22000

12002

12003

32004

22005

12006

12007

12009

22017

12021

12022

12024

FDA listed device types

showing 8 of 24

Retainer, Matrix 1Eraser, Dental Stain 1Disk, Abrasive 1Applicator, Resin 1Wheel, Polishing Agent 1Tray, Impression, Preformed 1Syringe, Restorative And Impression Material 1Point, Abrasive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240714	Insure® Universal; Insure® Universal Automix	2024-07-24
US	K222435	Renamel® Microhybrid ;Renamel® Flowable Microhybrid	2022-10-11
US	K211259	Renamel Bulkfill	2021-06-24
BR	80424450010	Top Finisher System	Class I
BR	80424450012	Bandas de Matriz Cosmedent	Class I
BR	80424450006	PASTA PARA POLIMENTO DE MATERIAIS DENTÁRIOS TOP FINISHER	Class I

COSMEDENT, INC.

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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