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

Zhermack S.P.A.: FDA-registered device maker in BADIA POLESINE (RO) Rovigo, Italy, 14 510(k) clearances

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

Zhermack S.P.A. is registered with the FDA (registration 9614794) in BADIA POLESINE (RO) Rovigo, Italy. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 26, 2009. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614794
FEI number: 3003762341
Address: Via Bovazecchino, 100, BADIA POLESINE (RO) Rovigo, Italy, 45021
Owner or operator: DENTSPLY SIRONA INC (2511302)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: July 11, 2000
Registered through: 2026
Brand names listed: Aquasil Ulta+ Smart Wetting IMpression Material, Elite Glass, Elite HD+, Elite HD+ Maxi Tray Material, Elite HD+ Monophase, Elite HD+ Putty Soft, Elite HD+ Tray Material, Freealgin and more

Devices it lists

Device	Product code	Class	Role	Source
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Manufacturer, Specification developer	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
March 26, 2009	K083739	HYDRORISE AND HYDROSYSTEM	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
March 14, 2008	K080130	OCCLUFAST CAD	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
December 12, 2007	K073005	ELITE GLASS	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
April 25, 2007	K070700	FREEALGIN	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
July 15, 2005	K051424	HYDROGUM 5	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
January 24, 2005	K043118	HYDROGUM SOFT	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
December 15, 2004	K043131	TORPICALGIN	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
December 18, 2002	K024034	OCCLUFAST ROCK	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
October 28, 2002	K022653	ELITE MONOPHASE	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
May 21, 1998	K981091	NEOCOLLOID, ORTHOPRINT	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
January 29, 1998	K974704	HYDROGUM	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
August 1, 1997	K972239	ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
July 16, 1997	K972027	ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
May 27, 1994	K940860	CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS	ELW	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 26, 2009. 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.