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SATELEC A COMPANY OF ACTEON GROUP

France · Merignac

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel — 7 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

15listed device types

Class I 6Class II 8Class III 0unclassified 1

plus 42 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

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

17active device licences

Class II 16Class III 1

49 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

17active ARTG entries

Class I 2IIa 10IIb 3Class Is (sterile) 2

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

2registrations

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 States42 registration records, 12 510(k), 0 PMA, 1 excluded

Brazil6 confirmed, 1 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: SATELEC-ACTEON GROUP · SATELEC A COMPANY OF ACTEON GROUP · SATELEC ACTEON INC.

FDA 510(k) clearances by year

22007

32012 · K113430

12013 · K131997

42014 · K131906

12018 · K172137

12024 · K233922

FDA listed device types

showing 8 of 15

Controller, Foot, Handpiece And Cord 1Handpiece, Direct Drive, Ac-Powered 1Handpiece, Air-Powered, Dental 1Unit, Operative Dental 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Otoscope 1Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Activator, Ultraviolet, For Polymerization 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233922	SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG	2024-03-11
US	K172137	PIEZOTOME CUBE	2018-05-03
US	K131906	SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE	2014-04-11
BR	80840260013	ULTRASSOM ODONTOLÓGICO	Class II
BR	80840260008	NEWTRON P5	Class II
BR	80840269005	newtron booster	Class II
CA	20395	NEOSONO ULTIMA EZ APEX LOCATOR/PULP TESTER	Class II
CA	20393	TEAM UP	Class II
CA	20394	SUPRASSON P5 BOOSTER	Class II

SATELEC A COMPANY OF ACTEON GROUP

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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