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Planmeca Oy

Finland · Helsinki

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

9listed device types

Class I 3Class II 6Class III 0

plus 14 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

12active device licences

Class II 12

23 including historic records

TWTaiwanTFDA

10valid device licences

Class I 1Class II 9

SGSingaporeHSA SMDR

5device registrations

CLASS B 1CLASS C 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 3IIa 2IIb 9

HKHong KongMDACS

4valid listings

Class II 2Class III 2

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

12active registrations

Class 1 2Class 2a 5Class 2b 5

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 States14 registration records, 28 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: Planmeca Oy · PLANMECA OY

FDA 510(k) clearances by year

11993

21995

21996

41997

11998

11999

42000

12001

12005

12006

12007

12009

12010

12011

12014

12016

12017

12018

12020

12023

FDA listed device types

showing 8 of 9

Unit, Operative Dental 1Light, Operating, Dental 1Chair, Dental, Without Operative Unit 1Light Transmission Caries Detector 1System, Image Processing, Radiological 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1X-Ray, Tomography, Computed, Dental 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230985	Planmeca Viso	2023-12-28
US	K200572	Planmeca Romexis	2020-12-02
US	K181576	Planmeca Viso	2018-09-13
BR	80117580756	PLANMECA ROMEXIS	Class II
SA	ME0000007759SFDAA00010	Planmeca Solanna	—
SA	ME0000007759SFDAA00011	Planmeca SingLED	—
CA	66356	INTRA - INTRAORAL X-RAY SYSTEM	Class II
CA	66357	DIXI 2	Class II
CA	66358	PROLINE CC - FILM PANORAMIC X-RAY	Class II