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Bredent GmbH & Co. KG

Germany · Senden

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Russia — 7 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

13listed device types

Class I 7Class II 6Class III 0

plus 14 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

32 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 5

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

18active ARTG entries

Class I 3IIa 15

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

11active registrations

Class 2a 11

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 States14 registration records, 3 510(k), 0 PMA, 1 excluded

Saudi Arabia8 confirmed, 0 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: BREDENT GMBH & CO.KG · BREDENT GMBH & CO. KG · bredent GmbH & Co. KG

FDA 510(k) clearances by year

12010 · K101064

12016 · K152113

12024 · K240735

FDA listed device types

showing 8 of 13

Attachment, Precision, All 1Wax, Dental, Intraoral 1Tray, Impression, Preformed 1Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer 1Protector, Silicate 1Drill, Dental, Intraoral 1Pin, Retentive And Splinting, And Accessory Instruments 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240735	visio.lign color, visio.lign shield	2024-12-12
US	K152113	BioHPP - breCAM.BioHPP	2016-07-21
US	K101064	BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P	2010-09-14
SA	ME0000011407SFDAA00022	Tray Material UV	—
SA	ME0000011407SFDAA00001	beauty setup	—
CA	81599	FRICTION SPLINT FS1 PIN (DENTAL ATTACHMENT)	Class II
CA	81600	VKS-OC/SG EXCHANGEABLE STUD WITH ADHESIVE SLEEVE (DENTAL ATTACHMENT)	Class II
CA	81602	FRICTION SPLINT FS1 SLEEVE (DENTAL ATTACHMENT)	Class II

Bredent GmbH & Co. KG

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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