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BIODENTA SWISS AG

Switzerland · Berneck

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Russia — 4 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

3listed device types

Class I 1Class II 2Class III 0

plus 10 registration records and 11 510(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

2active device licences

Class II 1Class III 1

TWTaiwanTFDA

8valid device licences

Class I 5Class II 2Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2b 1

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 States10 registration records, 11 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: BIODENTA SWISS AG

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151295	Biodenta Customized Abutment - Titanium	2015-12-01
US	K150296	Biodenta Customized Abutment-Hybrid	2015-07-02
US	K133884	BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM	2014-06-13
CA	90623	BIODENTA - DENTAL IMPLANT SYSTEM, INSTRUMENTS	Class II
CA	91346	BIODENTA DENTAL IMPLANT SYSTEM	Class III

BIODENTA SWISS AG

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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