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ZIRKONZAHN GMBH/ SRL

Italy · Gais

✓ 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

18listed device types

Class I 6Class II 11Class III 0unclassified 1

plus 21 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

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

3active device licences

Class II 3

24 including historic records

TWTaiwanTFDA

8valid device licences

Class I 4Class II 4

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

21active ARTG entries

Class I 9IIa 11IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 States21 registration records, 11 510(k), 0 PMA

Brazil6 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: ZIRKONZAHN SRL · ZIRKONZAHN GMBH/ SRL

FDA 510(k) clearances by year

12006

12014

12015

22018

22019

12020

12021

12022

12023

FDA listed device types

showing 8 of 18

System, Image Processing, Radiological 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Alloy, Metal, Base 1Crown And Bridge, Temporary, Resin 1Material, Tooth Shade, Resin 1Denture Preformed (Partially Prefabricated Denture) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232691	Polibond	2023-09-05
US	K213722	ICE Ceramics, ICE Stains, Fresco	2022-12-14
US	K203765	ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray	2021-07-20
BR	81220900004	BLOCOS DE TITANIO ZIRKONZAHN	Class II
BR	81220900002	BLOCOS DE CR-CO ZIRKONZAHN	Class II
BR	10351890017	Sintermetal	Class II
CA	97929	BURNOUT, TRY-IN & BURNOUT	Class II
CA	97940	TEMP BASIC X-RAY AND TRY-IN	Class II
CA	100073	ZZ BASE WSM (WHITE SCANMARKER)	Class II

ZIRKONZAHN GMBH/ SRL

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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