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Heraeus Kulzer, Inc., Dental Products Division

USA · South Bend

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

173510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 173 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

18active device licences

Class II 7Class III 11

20 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 States0 registration records, 173 510(k), 0 PMA, 5 excluded

Brazil0 confirmed, 2 excluded

Canada18 confirmed, 3 excluded

Manufacturer names merged into this page: HERAEUS KULZER GMBH · HERAEUS KULZER DENTAL LTD.

Same-named companies — This database also contains companies with near-identical names: Heraeus Kulzer GmbH & Co. KG, HERAEUS KULZER DENTAL LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160049	Charisma	2016-11-15
US	K150933	iBond Universal & iBond Ceramic Primer	2015-07-07
US	K130647	XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML	2013-05-17
CA	6673	DENTHESIVE II DENTIN BONDING AGNET	Class II
CA	12511	SOLITAIRE	Class III
CA	14227	GLUMA ONE BOND	Class III

Heraeus Kulzer, Inc., Dental Products Division

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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