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ALTATEC GMBH

Germany · Wimsheim

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia — 5 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

6listed device types

Class I 4Class II 2Class III 0

plus 17 registration records and 14 510(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

9active device licences

Class II 8Class III 1

32 including historic records

TWTaiwanTFDA

37valid device licences

Class I 4Class II 26Class III 7

SGSingaporeHSA SMDR

7device registrations

CLASS B 1CLASS C 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

34active ARTG entries

Class I 12IIa 14IIb 8

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 States17 registration records, 14 510(k), 0 PMA, 2 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: ALTATEC GMBH

FDA 510(k) clearances by year

12006

12007

12008

22009

12011

12012

12014

22015

32016

12020

FDA listed device types

Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Accessories, Implant, Dental, Endosseous 1Bur, Dental 1Tray, Surgical, Instrument 1Chisel, Osteotome, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193401	Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants	2020-09-29
US	K160784	CAM Titanium Blanks	2016-09-14
US	K153779	Abutment for Bridges	2016-03-31
CA	79102	CAMLOG BIOTECHNOLOGIES SURGERY SET SCREW-LINE	Class II
CA	79633	CAMLOG ABUTMENT SCREW	Class III
CA	81118	LAMELLA RETENTION INSERT E	Class II

ALTATEC GMBH

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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