Home›Germany›Medentika GmbH

Medentika GmbH

Germany · Hugelsheim

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Russia — 7 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

4listed device types

Class I 1Class II 3Class III 0

plus 26 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

30registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 1Class III 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

25active ARTG entries

Class I 12IIa 9IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

20active registrations

Class 1 10Class 2a 5Class 2b 5

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 States26 registration records, 10 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia30 confirmed, 0 excluded

Manufacturer names merged into this page: Medentika GmbH · MEDENTIKA GMBH · MEDENTiKA GmbH

FDA 510(k) clearances by year

22015

12017 · K170838

12019 · K180564

32020 · K201711

12024 · K223113

22025 · K253341

FDA listed device types

Dental Abutment Design Software For Dental Laboratory 1Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253341	Custom Abutments AS	2025-12-23
US	K242542	Medentika CAD/CAM Abutments	2025-04-22
US	K223113	Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments	2024-04-15
BR	10344420513	CONECTOR LINK MEDENTIKA®	Class I
BR	10344420501	TITANIUM SCANBODY MEDENTiKA®	Class II
SA	ME0000011408SFDAA00007	Placement instrument	—
SA	ME0000011408SFDAA00009	Torque ratchet	—

Medentika GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies