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CARESTREAM DENTAL, LLC.

USA · Atlanta

✓ 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

11listed device types

Class I 5Class II 6Class III 0

plus 34 registration records and 1 510(k), 5 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

8 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

9active device licences

Class II 5Class III 4

29 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

11device registrations

CLASS B 3CLASS C 8

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 5IIa 3IIb 3Class Im (measuring) 2

HKHong KongMDACS

5valid listings

Class II 2Class III 3

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 2b 4

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 States34 registration records, 1 510(k), 5 PMA, 10 excluded

Brazil2 confirmed, 5 excluded

Saudi Arabia3 confirmed, 1 excluded

Canada9 confirmed, 3 excluded

Manufacturer names merged into this page: Carestream Dental Technology Topco Limited · Carestream Dental LLC · CARESTREAM DENTAL, LLC · CARESTREAM DENTAL, LLC. · CARESTREAM DENTAL BRASIL LTDA · CARESTREAM DENTAL LLC

FDA 510(k) clearances by year

12012 · K122427

FDA listed device types

showing 8 of 11

Unit, Operative Dental 1Screen, Intensifying, Radiographic 1Camera, Surgical And Accessories 1Film, Radiographic 1Holder, Film, X-Ray 1System, Image Processing, Radiological 1System, X-Ray, Extraoral Source, Digital 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K122427	CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE	2012-09-12
BR	81522400005	DIGITALIZADOR DE IMAGENS RADIOGRÁFICAS	Class I
BR	81522409001	Sistema Digital de Imagem Intraoral	Class II
SA	ME0000015622SFDAA00002	Intraoral Camera	—
SA	ME0000015622SFDAA00003	Intraoral Camera	—
CA	76997	CS 9000 3D EXTRAORAL IMAGING SYSTEM	Class III
CA	79617	CS 9000C 3D EXTRAORAL IMAGING SYSTEM	Class III
CA	88460	CS 9300	Class III

CARESTREAM DENTAL, LLC.

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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