VERTEX-DENTAL BV

Netherlands · Soesterberg

✓ 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

12listed device types

Class I 7Class II 4Class III 0unclassified 1

plus 15 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 4Class II 5

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

16active device licences

Class II 16

17 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 States15 registration records, 8 510(k), 0 PMA, 2 excluded

Brazil9 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: VERTEX-DENTAL B.V. · VERTEX-DENTAL BV · Vertex-Dental.B.V. · Vertex-Dental.B.V

FDA 510(k) clearances by year

12010

12011

12013

12017

12019

12022

12023

12024

FDA listed device types

showing 8 of 12

Crown And Bridge, Temporary, Resin 1Material, Tooth Shade, Resin 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1Plate, Base, Shellac 1Maintainer, Space Preformed, Orthodontic 1Positioner, Tooth, Preformed 1Teeth, Artificial, Backing And Facing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241071	NextDent Jet Denture Base; NextDent Jet Denture Teeth	2024-09-04
US	K231388	NextDent Base	2023-10-20
US	K221022	NextDent Ortho Flex	2022-10-21
BR	81504799256	NextDent Jet Teeth	Class II
BR	81504799257	NextDent Jet Base	Class II
BR	81504799012	NEXTDENT DENTURE 3D+	Class II
SA	ME0000003698SFDAA00001	Ceramill SG	—
SA	ME0000003697SFDAA00001	Ceramill Ortho IBT	—
CA	78063	VERTEX CASTAPRESS	Class II
CA	78064	VERTEX SOFT	Class II
CA	78065	VERTEX RAPID SIMPLIFIED	Class II

VERTEX-DENTAL 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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