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Kulzer, Inc.

Germany · South Bend

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

30listed device types

Class I 16Class II 13Class III 0unclassified 1

plus 114 registration records and 38 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 2Class II 17

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

19active device licences

Class II 4Class III 15

46 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

18active ARTG entries

Class I 5IIa 13

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

20active registrations

Class 1 3Class 2a 17

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 States114 registration records, 38 510(k), 0 PMA, 7 excluded

Brazil19 confirmed, 1 excluded

Canada19 confirmed, 3 excluded

Manufacturer names merged into this page: KULZER GMBH · Kulzer SRL · KULZER, LLC

FDA 510(k) clearances by year

31981

11982

21983

21984

11985

31986

11988

51989

71990

61991

12022

12023

22024

22025

12026

FDA listed device types

showing 8 of 30

Frame, Rubber Dam 1Amalgamator, Dental, Ac-Powered 1Instruments, Dental Hand 1Clamp, Rubber Dam 1Maintainer, Space Preformed, Orthodontic 1Disk, Abrasive 1Wax, Dental, Intraoral 1Syringe, Restorative And Impression Material 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260783	Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One	2026-03-11
US	K254063	iCEM Universal Plus	2025-12-19
US	K243910	Retraxil	2025-09-24
BR	10166849016	Dima Print Teeth & Temp	Class II
BR	10166840063	HERACERAM (CERAMICA DENTAL)	Class II
BR	10166840072	DENTES ACRILICOS	Class II
CA	6284	N.T.I. CLENCHING SUPPRESSION SYSTEM	Class II
CA	6447	ADVANCE FORMULA ACCELAR	Class II
CA	14224	GLUMA SOLID BOND	Class III

Kulzer, Inc.

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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