Data / Medical devices / Italy / Mectron S.P.A.

Mectron S.P.A.: FDA-registered device maker in CARASCO Genova, Italy, 12 510(k) clearances

Name: Mectron S.P.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mectron S.P.A. is registered with the FDA (registration 3003933619) in CARASCO Genova, Italy. It lists 9 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 19, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003933619
Address: 15, Via Loreto, CARASCO Genova, Italy, 16042
Owner or operator: MECTRON S.P.A. (9078459)
Roles: Complaint file establishment, Manufacturer
First device listed: November 23, 2009
Registered through: 2026
Brand names listed: BONE EXPANDERS, COMPACT PIEZO LED, Compact Piezo P2K - Powercare, K10, K6, MT-Bone, MT11L-10, MT11R-10 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Manufacturer	accessdata.fda.gov
Airbrush	KOJ	2	Manufacturer	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Sonic And Accessory/Attachment	JDX	2	Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 19, 2024	K242432	MT-Bone	DZI	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
May 15, 2023	K231391	Combi Touch	ELC	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
January 12, 2018	K171958	PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE	DZI	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
May 25, 2016	K153743	PIEZOSURGERY PLUS	JDX	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
September 4, 2015	K151248	PIEZOSURGERY WHITE	DZI	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
August 5, 2015	K151023	COMPACT PIEZO LED	ELC	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
August 20, 2014	K140965	MULTIPIEZO PRO, MULTIPIEZO	ELC	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
November 29, 2013	K132848	PIEZOSURGERY FLEX	JDX	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
December 6, 2012	K122322	PIEZOSURGERY TOUCH	DZI	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
January 24, 2011	K102218	COMPACT PIEZO P2K, POWERCARE	ELC	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
December 29, 2009	K091227	PIEZOSURGERY 3; OSSTEM PIEZO	DZI	Substantially Equivalent	Piezosurgery S.R.L.	accessdata.fda.gov
December 7, 2009	K092951	STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS	EBZ	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov

Compare with other makers

Updated August 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.