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Straumann Manufacturing, Inc.

USA · Mansfield

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, South Korea — 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

11listed device types

Class I 1Class II 10Class III 0

plus 114 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

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 States114 registration records, 4 510(k), 0 PMA, 12 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Straumann Manufacturing, Inc. · Straumann Manufacturing Inc.

FDA 510(k) clearances by year

12007 · K070478

12008 · K080239

22009 · K092814

FDA listed device types

showing 8 of 11

Driver, Wire, And Bone Drill, Manual 1System, Image Processing, Radiological 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Alloy, Metal, Base 1Dental Abutment Design Software For Dental Laboratory 1Abutment, Implant, Dental, Endosseous 1Material, Tooth Shade, Resin 1Powder, Porcelain 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K092814	STRAUMANN DENTAL ABUTMENTS	2009-12-15
US	K090260	MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS	2009-02-26
US	K080239	P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS	2008-04-30

Straumann Manufacturing, Inc.

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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