Cavex Holland BV

Netherlands · Haarlem (Holland)

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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 9Class II 5Class III 0

plus 23 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 1Class II 8

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

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 States23 registration records, 26 510(k), 0 PMA

Brazil9 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: CAVEX HOLLAND B.V. · CAVEX HOLLAND B. V. · Cavex Holland BV

FDA 510(k) clearances by year

91998

12000

42001

22002

12003

12004

22005

22006

12007

12008

12014

12015

FDA listed device types

showing 8 of 14

Cement, Dental 1Additively Manufactured, Preformed, Resin Denture Tooth 1Material, Tooth Shade, Resin 1Material, Impression 1Agent, Tooth Bonding, Resin 1Plate, Base, Shellac 1Wax, Dental, Intraoral 1Syringe, Periodontic, Endodontic, Irrigating 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151535	Cavex Cream Alginate	2015-10-28
US	K141092	MARK3	2014-12-04
US	K073539	PROVISA CEM	2008-01-31
BR	80033549012	cavex bite & white ready 2 use	Class II
BR	80033549006	Cavex ExSense	Class II
BR	80033540016	Alginatos Cavex	Class II
SA	ME0000013129SFDAA00001	Cavex Cream Alginate	—

Cavex Holland BV

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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