Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614794

FEI Number

3003762341

Entity Name

ZHERMACK S.P.A.

City/State/Country

BADIA POLESINE (RO) Rovigo, IT

Establishment Address

VIA BOVAZECCHINO, 100, BADIA POLESINE (RO) Rovigo 45021, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DENTSPLY SIRONA INC (Owner Number: 2511302)

Owner / Operator Contact Address

221 WEST PHILADELPHIA ST., SUITE 60W, York, PA 17401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silgimix Alginate Replacement Hydrogum Alginate Reprosil Regisil Tray Adhesive Virtual Intra Oral Tips Oral Tips Mixing Tips Virtual Mixing Tips Virtual Dispenser Intra Oral Tips Freealgin Tropicalgin Alginate Hydrogum 5 Alginate Elite HD+ Putty Soft Jeltrate Plus Elite HD+ Monophase Elite HD+ Tray Material Elite HD+ Maxi Tray Material Elite Glass Jeltrate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2008-04-16
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2002-03-18
ELW	Material, Impression	Dental	Class 2	872.3660	2012-02-15
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2008-04-16
ELW	Material, Impression	Dental	Class 2	872.3660	2008-03-13
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2000-07-11
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2008-03-13
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-10-25
ELW	Material, Impression	Dental	Class 2	872.3660	2008-03-13

Official Correspondent

No official correspondent registered.

US Agent Details

Dan Eagar Business: DENTSPLY SIRONA INC Email: dan.eagar@dentsplysirona.com Phone: (704) 4926977

Related Public Records

Same Entity

DENTSPLY SIRONA INC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9612618	DEGUDENT GMBH	Rosbach V.D.H. Hesse, DE
3003756493	DENTSPLY INDUSTRIA E COMERCIO LTDA	PIRASSUNUNGA Sao Paulo, BR
3001226627	RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)	ST. EGREVE Isere, FR
3003136642	OraMetrix GmbH	Berlin Brandenburg, DE
3000303964	DENTSPLY DENTAL (TIANJIN) CO., LTD.	TEDA Tianjin, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

Similar Registrations

Registration Number	Establishment Name	Location
3030268763	OWL DENTAL	San Leandro, CA, US
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 9614794. Last updated year: 2026. Please use registration number 9614794 when referencing this establishment in official correspondence.