VOCO GMBH

Germany · Cuxhaven

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

41listed device types

Class I 23Class II 16Class III 0unclassified 2

plus 119 registration records and 119 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

89registered devices

Class I 11Class II 78

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

48active device licences

Class II 6Class III 42

147 including historic records

TWTaiwanTFDA

45valid device licences

Class I 6Class II 39

SGSingaporeHSA SMDR

10device registrations

CLASS B 10

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

41active ARTG entries

Class I 21IIa 20

HKHong KongMDACS

4valid listings

Class II 4

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 States119 registration records, 119 510(k), 0 PMA

Brazil89 confirmed, 1 excluded

Canada48 confirmed, 0 excluded

Manufacturer names merged into this page: VOCO GMBH

FDA 510(k) clearances by year

72006

42007

32008

52009

72010

82011

22012

22013

32014

42015

52016

32017

22018

22019

52020

12021

32022

32023

22025

32026

FDA listed device types

showing 8 of 41

Sealant, Pit And Fissure, And Conditioner 1Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Adhesive, Bracket And Tooth Conditioner, Resin 1Liner, Cavity, Calcium Hydroxide 1Crown And Bridge, Long-Term Temporary, Resin 1Dental Barriers And Sleeves 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252073	VOCO Profluorid Varnish + BioMin	2026-05-01
US	K261357	Grandio disc multicolor	2026-04-27
US	K252606	Bifix Veneer LC, Bifix Veneer Try-In	2026-03-20
BR	80230409007	Calcimol LC	Class II
BR	80230409008	Meron	Class II
BR	80230409009	Bifluorid 10 SingleDose	Class II
CA	10188	UFI GEL HARD	Class II
CA	10533	AQUALOX	Class III
CA	10568	THERMOLINE	Class III