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NOBEL BIOCARE AB

Sweden · Goteborg

✓ 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

38listed device types

Class I 14Class II 23Class III 1

plus 400 registration records and 141 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

62registered devices

Class I 42Class II 20

71 including historic records

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

42active device licences

Class II 9Class III 33

97 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

63device registrations

CLASS B 18CLASS C 45

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

60active ARTG entries

Class I 22IIa 16IIb 20Class Im (measuring) 2

HKHong KongMDACS

11valid listings

Class II 3Class III 8

ILIsraelAMAR

51registrations

RURussiaRoszdravnadzor

39active registrations

Class 1 10Class 2a 10Class 2b 19

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 States400 registration records, 141 510(k), 0 PMA, 1 excluded

Brazil62 confirmed, 1 excluded

Saudi Arabia9 confirmed, 2 excluded

Canada42 confirmed, 0 excluded

Manufacturer names merged into this page: NOBEL BIOCARE AB · NOBEL BIOCARE DISTRIBUTION CENTER BV · NOBEL BIOCARE AB, PRODUKTION · NOBEL BIOCARE USA, LLC · NOBEL BIOCARE USA LLC · NOBEL BIOCARE AB SUÉCIA

Same-named companies — This database also contains companies with near-identical names: NOBEL BIOCARE DISTRIBUTION CENTER BV, Nobel Biocare Services AG, NOBEL BIOCARE USA, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

122006

92007

42008

72009

42010

32011

32013

42014

12015

92016

92017

62018

32019

52020

32021

32022

42023

12024

32025

22026

FDA listed device types

showing 8 of 38

Bone Grafting Material, Animal Source 1Dental Stereotaxic Instrument 1Mask, Surgical 1Prosthesis, Nose, Internal 1General Surgery Tray 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Implant, Endosseous, Root-Form 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw	2026-08-06
US	K252197	Nobel Biocare S Series Implants	2026-02-18
US	K252086	DTX Studio Assist	2025-11-17
BR	10064010224	KIT PARA INSERÇÃO DE IMPLANTE NOBELREPLACE PLATFORM SHIFT PARA CIRURGI	Class I
BR	10064010185	Kit de Brocas 7 - 15 mm	Class II
BR	10064010219	KIT PARA INSERÇÃO DE IMPLANTE NOBELREPLACE CONICAL CONNECTION PARA CIR	Class I
SA	ME0000001953SFDAA00009	Multi unit Abutment	—
SA	ME0000001953SFDAA00170	Impression Coping	—
CA	16381	NOBEL BIOCARE DENTAL IMPLANT SYSTEM	Class III
CA	1332	IMZ MEMBRANE TACK SYSTEM	Class III
CA	1338	IMZ/INTERPORE DENTAL IMPLANT SYSTEM	Class III

NOBEL BIOCARE AB

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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