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INSTITUT STRAUMANN AG

Switzerland · Basel

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

28listed device types

Class I 9Class II 17Class III 1unclassified 1

plus 166 registration records and 97 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

77registered devices

Class I 38Class II 39

129 including historic records

SASaudi ArabiaSFDA

57registered imported devices

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

CACanadaMDALL

16active device licences

Class II 10Class III 5Class IV 1

114 including historic records

TWTaiwanTFDA

4valid device licences

Class I 2Class II 1Class III 1

SGSingaporeHSA SMDR

51device registrations

CLASS B 18CLASS C 30CLASS D 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

63active ARTG entries

Class I 15Class III 4IIa 38IIb 6

HKHong KongMDACS

8valid listings

Class III 7Class IV 1

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

43active registrations

Class 1 16Class 2a 16Class 2b 9Class 3 2

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 States166 registration records, 97 510(k), 0 PMA, 9 excluded

Brazil77 confirmed, 4 excluded

Saudi Arabia57 confirmed, 0 excluded

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: INSTITUT STRAUMANN AG · Institut Straumann AG

FDA 510(k) clearances by year

22002

42004

12005

42006

72007

42008

42009

22010

12012

32016

92017

102018

92019

52020

72021

42022

32023

32024

32025

42026

FDA listed device types

showing 8 of 28

Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Screw, Fixation, Intraosseous 1Barrier, Synthetic, Intraoral 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Alloy, Metal, Base 1Dental Abutment Design Software For Dental Laboratory 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260726	Straumann® ProClean Cassette (041.800 ; 041.801)	2026-06-03
US	K260460	Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue	2026-05-07
US	K252168	Straumann® BLC Implants - Indication Widening	2026-03-10
BR	10344420321	TRANSFERENTE DE MOLDEIRA STRAUMANN(R)	Class II
BR	10344429012	Kit Service Set para implante BLX Straumann®	Class II
BR	10344429013	Kit Service Set para Interface SC Straumann®	Class II
SA	ME0000015199SFDAA00101	NNC Analog for Solid abutment	—
SA	ME0000015199SFDAA00093	WN Analog for Solid Abutment 048.546, L 17.5mm, brown, Al	—
CA	23283	EO IMPLANT SYSTEM	Class III
CA	34812	STRAUMANN ORTHOSYSTEM	Class III
CA	66785	ORTHO PROFILE DRILL	Class II

INSTITUT STRAUMANN 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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