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Espe Dental AG

Germany · Bavaria Seefeld

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

75510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 75 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

74registered devices

Class I 19Class II 55

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

28active device licences

Class II 7Class III 21

62 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States0 registration records, 75 510(k), 0 PMA, 4 excluded

Brazil74 confirmed, 2 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada28 confirmed, 1 excluded

Manufacturer names merged into this page: 3M ESPE DENTAL PRODUCTS · 3M COMPANY - 3M ESPE DENTAL PRODUCTS · 3M COMPANY 3M ESPE DENTAL PRODUCTS · 3 M ESPE DENTAL PRODUCTS · 3M ESPE Dental Products

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231338	3M Clinpro Clear 2.1% Sodium Fluoride Treatment	2023-05-10
US	K230270	3M VitCal Liner/Base	2023-02-06
US	K221695	3M Filtek Supreme Flowable Restorative	2022-06-13
BR	10002070008	3M ESPE VITREMER IONOMERO DE VIDRO PARA RESTAURAÇÃO E CONSTRUÇÃO DE NÚ	Class II
BR	10002070027	3M ESPE ADPER SCOTCHBOND MULTIUSO PLUS	Class II
BR	83255939013	3M Filtek Supreme Flowable Restorative	Class II
SA	ME0000009304SFDAA00098	Imprint II Garant Heavy Body Vinyl Polysiloxane Impression Material	—
SA	ME0000009304SFDAA00100	3M ESPE Unitek Stainless Steel Primary Molar Crowns	—
CA	6535	3M ISO-TEMP TEMPORARY MATERIAL	Class III
CA	6543	SCOTCHBOND RESIN CEMENT	Class II
CA	6917	3M CONCISE ORTHODONTIC BONDING SYSTEM	Class II

Espe Dental AG

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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