Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006644229

FEI Number

3006644229

Entity Name

GHIMAS SPA

City/State/Country

Casalecchio di Reno Bologna, IT

Establishment Address

Via Cimarosa 85-40033, Casalecchio di Reno Bologna 75369, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Ghimas SPA (Owner Number: 10034681)

Owner / Operator Contact Address

Via Cimarosa 85, Casalecchio di Reno, IT-BO 40033, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-12-22
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2022-09-21

Official Correspondent

Alberto Poletti

US Agent Details

Joseph Jones Business: VP of Temrex Corp. Email: mltemrex@temrex.com Phone: (516) 8686221

Related Public Records

Same Entity

Ghimas 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
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Similar Registrations

Registration Number	Establishment Name	Location
8030419	SUN MEDICAL CO., LTD.	Moriyama Shiga, JP
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006644229. Last updated year: 2026. Please use registration number 3006644229 when referencing this establishment in official correspondence.