Home›USA›Straumann USA, Inc.

Straumann USA, Inc.

USA · Andover

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

2listed device types

Class I 0Class II 2Class III 0

plus 1 registration records and 71 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States1 registration records, 71 510(k), 0 PMA, 8 excluded

Brazil2 confirmed, 4 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Straumann USA, LLC · STRAUMANN USA

FDA 510(k) clearances by year

12002

42003

12005

22006

72007

32008

12009

22010

52011

52012

42013

62014

72015

22016

32017

12018

12019

22020

22021

12024

FDA listed device types

Dental Abutment Design Software For Dental Laboratory 1Abutment, Implant, Dental, Endosseous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241575	Straumann® Anatomic Healing Abutments XC (AHA)	2024-11-11
US	K203753	Straumann Surgical Cassettes	2021-07-29
US	K202942	Straumann 4 mm Short Implants	2021-02-08
BR	10344420130	PINOS PARA MOLDAGEM DO STRAUMANN DENTAL IMPLANTE SYSTEM	Class II
BR	10344420145	PROMOTOR DE ROSCA BL/TE PARA ADAPTADOR DO STRAUMANN DENTAL IMPLANT SYS	Class II

Straumann USA, Inc.

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