Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001561923

FEI Number

3001561923

Entity Name

LEONE SPA

City/State/Country

Sesto Fiorentino Firenze, IT

Establishment Address

50, VIA P. A QUARACCHI, Sesto Fiorentino Firenze I-50019, IT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

LEONE SPA (Owner Number: 9051868)

Owner / Operator Contact Address

50, Via P. a Quaracchi, Sesto Fiorentino, IT-FI I-50019, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Band driver and adapter MEMORIA CALIBRA WEB LEOLOY BIOSTELL LEOWIRE MEMORIA Orthodontic headgear, facemask/bow AQUA/Ceramic brackets Surgical instruments Noble alloys MIDI DIAGONALI MINI DIAGONALI METAL BRACKETS Orthodontic ligature instruments Pliers, operative Impression Tray Orthodontic pliers and instruments METAL TUBES MIM Thermoplastic material Mandibular advancers LEONE EXPANDERS Lip retractor BURS DRILLS Leone Orthodontic Mini Implant MEMORIA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2007-11-02
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2002-06-27
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2002-06-27
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2002-06-27
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2007-11-02
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2017-03-28
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2007-11-02
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2003-03-14
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2002-06-27
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2007-11-02
EJY	Pliers, Operative	Dental	Class 1	872.4565	2002-06-27
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2021-03-11
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2007-11-02
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2003-07-01
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2003-03-14
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2007-11-02
EJL	Bur, Dental	Dental	Class 1	872.3240	2003-07-01
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2008-03-03
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2002-06-27

Official Correspondent

Elena Pozzi

US Agent Details

Matt Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

LEONE SPA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001561923. Last updated year: 2026. Please use registration number 3001561923 when referencing this establishment in official correspondence.