Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021059

FEI Number

3007746785

Entity Name

LA.SC.OD. SPA

City/State/Country

FLORENCE, TUSCANY Firenze, IT

Establishment Address

VIA LONGO, 18 SESTO, FIORENTINO, FLORENCE, TUSCANY Firenze 50019, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LA.SC.OD. SPA (Owner Number: 8021059)

Owner / Operator Contact Address

VIA LONGO, 18 SESTO, FIORENTINO, FLORENCE, TUSCANY, IT-NOTA 50019, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121824

PMA Number

N/A

All Registered Proprietary Names

Ghenesyl Body Super Light Normal Set Kromopan Sil Fast Set Kit - Putty Soft + Super Light Body Kromopan Sil Body Light Fast Set Ghenesyl Body Light Normal Set Kromopan Sil Normal Set Kit - Putty Soft + Super Light Body Ghenesyl Fast Set Kit - Putty Soft + Light Body Ghenesyl Body Regular Fast Set Ghenesyl Mono Ghenesyl Fast Set Kit - Putty Soft + Super Light Body Ghenesyl Body Heavy Fast Set Ghenesyl Fast Set Kit - Putty Hard + Super Light Body Ghenesyl Normal Set Kit- Putty Soft + Super Light Body Kromopan Sil Body Heavy Fast Set Kromopan Sil Putty Hard Normal Set Ghenesyl Normal Set Kit - Putty Soft + Light Body Kromopan Sil Bite Kromopan Sil Body Regular Fast Set Ghenesyl Body Regular Normal Set Ghenesyl Putty Hard Normal Set Kromopan Sil Fast Set Kit - Putty hard + Light Body Kromopan Sil Normal Set Kit - Putty Hard + Super Light Body Ghenesyl Fast Set Kit - Putty Hard + Light Body Kromopan Sil Fast Set Kit - Putty Soft + Light Body Ghenesyl Putty Soft Fast Set Kromopan Sil Fast Set Kit - Putty Hard + Super Light Body Oklurest Ghenesyl Putty Soft Normal Set Kromopan Sil Normal Set Kit - Putty Soft + Light Body Ghenesyl Body Heavy Normal Set Ghenesyl Normal Set Kit- Putty Hard + Super Light Body Kromopan Sil Body Regular Normal Set Ghenesyl Body Light Fast Set Kromopan Sil Putty Hard Fast Set Ghenesyl Putty Hard Fast Set Kromopan Sil Normal Set Kit - Putty Hard + Light Body Kromopan Sil Body Super Light Normal Set Kromopan Sil Mono Kromopan Sil Body Heavy Normal Set Kromopan Sil Putty Soft Normal Set Kromopan Sil Putty Soft Fast Set Kromopan Sil Body Light Normal Set Ghenesyl Body Super Light Fast Set Kromopan Sil Body Super Light Fast Set Ghenesyl Normal Set Kit - Putty Hard + Light Body Exploit Millenium Alginor Alginelle IQ Kromopan Mono7

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2020-05-10
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2009-03-16
ELW	Material, Impression	Dental	Class 2	872.3660	2020-02-24

Official Correspondent

No official correspondent registered.

US Agent Details

Victoria Ricciardi Business: KROMOPAN U.S.A., INC. Email: KROMOPAN@SBCGLOBAL.NET Phone: (847) 4708503

Related Public Records

Same Entity

LA.SC.OD. 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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

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8021038	VANNINI DENTAL INDUSTRY SRL	GRASSINA(FI) Firenze, IT
2018957	DEN-MAT HOLDINGS, LLC	Lompoc, CA, US
3005558160	MAXILL, INC.	ST. THOMAS Ontario, CA
9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021059. Last updated year: 2026. Please use registration number 8021059 when referencing this establishment in official correspondence.