Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

4565

FEI Number

4565

Entity Name

MAJOR PRODOTTI DENTARI S.P.A.

City/State/Country

MONCALIERI Torino, IT

Establishment Address

VIA LUIGI EINAUDI 23, MONCALIERI Torino 10024, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAJOR PRODOTTI DENTARI S.P.A. (Owner Number: 9027488)

Owner / Operator Contact Address

VIA LUIGI EINAUDI 23, --, MONCALIERI, IT-TO 10024, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

major.base 20 AVM 100 MIT Light-Cure.Tray Light-Cure.Tray Orthochrome Alginplus Tropical Alginmajor Alginplus Fast Pointech Orthodontic Alginkid Algeniux Alginmax Michelangelo Alginate Valuline Pointech Normal temporary.cold.v self-cure.dentine Major Plus Comp Major Dent Bambino Tooth Major AF Comp Major Super Lux Major Plus Ormamax Ormalab 75 Ormaplus lab Ormadent Putty Ormaplus Ormactivator Ormalab 95 Ormalab 85 major.tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2008-11-17
EJP	Articulators	Dental	Class 1	872.3150	2008-03-12
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2008-05-22
ELW	Material, Impression	Dental	Class 2	872.3660	2006-03-16
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2009-01-09
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2008-03-12
ELW	Material, Impression	Dental	Class 2	872.3660	2008-03-12
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2008-05-22

Official Correspondent

No official correspondent registered.

US Agent Details

Kathleen Norton Business: AMERICAN TOOTH INDUSTRIES Email: regulatory@americantooth.com Phone: (805) 4879868

Related Public Records

Same Entity

MAJOR PRODOTTI DENTARI S.P.A.

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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
2950685	CO-ORAL-ITE DENTAL MFG. CO.	DIAMOND SPRINGS, CA, US
3032727	TALON ACRYLICS, INC.	Winchester, OR, US
3008320092	Shandong Huge Dental Material Corporation	Rizhao Shandong, CN
1410097	GC AMERICA INC.	ALSIP, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 4565. Last updated year: 2026. Please use registration number 4565 when referencing this establishment in official correspondence.