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VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.

Germany · Bad Sackingen

✓ 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

15listed device types

Class I 3Class II 11Class III 0unclassified 1

plus 45 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

20registered devices

Class II 20

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

2active device licences

Class III 2

32 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

21active ARTG entries

Class I 2IIa 19

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

15active registrations

Class 1 2Class 2a 13

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 States45 registration records, 13 510(k), 0 PMA

Brazil20 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. · VITA ZAHNFABRIK, H. RAUTER GMBH & CO. KG · VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG · VITA ZAHNFABRIK H. RAURER GMBH & CO.KG

FDA 510(k) clearances by year

22009

12010

12012

12014

12015

12016

12018

22020

12021

12025

12026

FDA listed device types

showing 8 of 15

Teeth, Porcelain 1Resin, Denture, Relining, Repairing, Rebasing 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Additively Manufactured, Preformed, Resin Denture Tooth 1Abutment, Implant, Dental, Endosseous 1Material, Tooth Shade, Resin 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251587	VITA VMLC Primer	2026-02-23
US	K243940	VITA YZ Multi Translucent	2025-02-21
US	K211854	VITA Akzent LC	2021-11-22
BR	10347940013	VITA VMK MASTER- PORCELANA PARA USO ODONTOLOGICO	Class II
BR	10347940015	VMK 95 - COMPOSTO DE CERAMICA EM PO	Class II
BR	10347940011	DENTES DE RESINA VITAPAN	Class II
CA	6706	VITA CELAY BLANKS	Class III
CA	10592	CROWN & BRIDGE ACRYLIC VENEERING SYSTEM	Class III

VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.

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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