Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030067

FEI Number

4108

Entity Name

SILMET LTD.

City/State/Country

OR YEHUDA Tel Aviv, IL

Establishment Address

12 HASADNA, OR YEHUDA Tel Aviv 6022011, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SILMET LTD. (Owner Number: 8030067)

Owner / Operator Contact Address

12A HASADNA, --, OR YEHUDA, IL-NOTA 6022011, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K760980

PMA Number

N/A

All Registered Proprietary Names

Universal Composite Hybrid Flowable ProFil ProFil Temp ProFil Flow LV ProFil Bulk ProFil Flow ProVeneer Flow ProFil Mono ProVeneer ProFil Seal ProFil Posterior Profil Universal ProFil Core ProFil Flow SE NOGAMA SPHERODON + PROCOPPER SPHERODON M DEXITER SPHERICAL AMALGAM DEXITER DISPERSED AMALGAM PROSILVER SPHERODON M Alloy regular NOGAMA Spherodon M Econom Ventura High Alloy PROSILVER SPHERODON + Amalgam dental alloy Avalloy DEXITER SPHERICAL AMALGAM DEXITER DISPERSED AMALGAM PROCOPPER Nualloy Ventura NG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-12-08
DZS	Capsule, Dental, Amalgam	Dental	Class 1	872.3110	1980-11-06
EJJ	Alloy, Amalgam	Dental	Class 2	872.3070	2008-05-26

Official Correspondent

MOSHE ZALSMAN

US Agent Details

Gavin Gabai Business: Cargus International Inc. Email: ggabai@cargus.com Phone: (845) 2672600

Related Public Records

Same Entity

SILMET LTD.

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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030067. Last updated year: 2026. Please use registration number 8030067 when referencing this establishment in official correspondence.