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MECTRON S.P.A.

Italy · Carasco

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Israel, Russia — 8 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 2Class II 7Class III 0

plus 13 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 2Class II 12

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

14active device licences

Class II 14

29 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 2Class 2a 5Class 2b 2

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 States13 registration records, 13 510(k), 0 PMA, 1 excluded

Brazil14 confirmed, 0 excluded

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: MECTRON S.P.A. · MECTRON S.P.A

FDA 510(k) clearances by year

12009

12011

12012

12013

12014

22015

12016

22018

12023

12024

12025

FDA listed device types

showing 8 of 9

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Activator, Ultraviolet, For Polymerization 1Scaler, Ultrasonic 1Airbrush 1Drills, Burrs, Trephines & Accessories (Simple, Powered) 1Drill, Bone, Powered 1Instrument, Surgical, Sonic And Accessory/Attachment 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251425	turbodent touch	2025-05-09
US	K242432	MT-Bone	2024-08-19
US	K231391	Combi Touch	2023-05-15
BR	80102519182	MICROPIEZO	Class II
BR	80102519438	Unidade de Cirurgia Óssea	Class II
BR	80102511364	DISPOSITIVO PIEZOELÉTRICO	Class II
CA	70181	PIEZOSURGERY	Class II
CA	70182	TURBODENT S (BICARBONATE-JET POLISHER)	Class II
CA	70183	COMBI S (POLISHER AND ULTRASONIC SCALER)	Class II

MECTRON S.P.A.

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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