Manufacturer registered with FDA

George Taub Products & Fusion Co., Inc.

Jersey City, NJ, United States. Lists 21 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator2241860ManufacturerRepacker / relabeler
Device types listed
21
Brands and models
33
510(k) clearances
21984–1986
Markets registered in
22 registrations outside the US
Establishments
1United States
1984: 11986: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 2 markets

Where regulators' registries name George Taub Products & Fusion Co., Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 21 device types listedSouth Korea: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerGeorge Taub Products & Fusion Co., Inc.2 clearances1984–1986Below
South KoreaMFDSManufacturerGEORGE TAUB PRODUCTS & FUSION CO. INC21999–2010Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What George Taub Products & Fusion Co., Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental CementEMA · Class 2Dental cementsMaker—2013
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
Tru-Paque
2007
Dental NeedleDZM · Class 1Dental needles & syringesLister
Tips - Applicator - Luer
2026
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsLister
Inlay/Onlay StyxVeneer Styx
1992
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesLister
Kidz Seal
2016
Resin Filling Material CoatingEBD · Class 2—Maker
Denture Base Staining KitGlaze KitL. M. D. ElixirsLarry's Magical Denture ElixirsMinute Stains
2007
Denture Repair KitEBO · Class 2—Maker
Fusion Kit
2007
Articulation PaperEFH · Class 1—Maker
BRIGHT SPOT IBRIGHT SPOT IIBRIGHT SPOT IIIBRIGHT SPOT IVBRIGHT SPOT VBRIGHT SPOT VITENDER SPOT
2006
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsLister
Tips - Auto Mix
2026
Rubber DamEIE · Class 1Rubber dam systemsMaker—2016
All Types RetractorEIG · Class 1Dental hand instrumentsLister
Mouth Gag - MoltTrident - Mouth Props
2020
Dental Wax CarverEIK · Class 1Dental hand instrumentsLister
WAX CARVER SET
1992
Crown RemoverEIS · Class 1Dental hand instrumentsLister
Expandable Crown SplitterTrident CPR crown placement & removerTrident IMPULSE Crown & Bridge Remover
2007
Calcium Hydroxide Cavity LinerEJK · Class 2—Maker
HYDROXYLINEHYDROXYLINE TC
2007
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisLister—2015
Operative Margin Finishing FileEKA · Class 1Dental hand instrumentsMaker
Trident Dental - Interproximal Saw Blade and Abrasive
2025
Operative BurnisherEKJ · Class 1Dental hand instrumentsLister
BALL BURNISHER
1992
Denture Preformed (Partially Prefabricated Denture)EKO · Class 2Denture resins & teethMaker
STELLAR AttachmentSTELLAR DC AcrylicSTELLAR LC Acrylic
2018
Paper Saliva AbsorberKHR · Class 1—Lister
SAL-DRI
1992
Resin ApplicatorKXR · Class 1—Lister—2019
External Cleaning SolutionPME · Class 2—Maker—2015

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names George Taub Products & Fusion Co., Inc. as the applicant.

Decided510(k)DeviceDevice type
4 Feb 1986K854588INSTA-GLAZEEJR Oral Cavity Abrasive Polishing Agent
27 Feb 1984K833640HYDROXYLINEEJK Calcium Hydroxide Cavity Liner

Also lists devices cleared under other names

George Taub Products & Fusion Co., Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Denali Corporation (7).

Decided510(k)DeviceApplicantDevice type
26 Feb 2016K153191Calcium BridgeDenali CorporationEBF Resin Tooth Shade Material
18 Feb 2016K151945Triumph Resin DamDenali CorporationEIE Rubber Dam
16 Dec 2015K152322Resolve 2.0Denali CorporationPME External Cleaning Solution
10 Nov 2014K141503DENALI 501CEMENTDenali CorporationEMA Dental Cement
14 Mar 2014K132393CERCOM II CEMENTDenali CorporationEMA Dental Cement
17 Jan 2008K073101AURAVENEER CEMENTDenali CorporationEMA Dental Cement
5 Jun 2007K071158AURALAY PIT & FISSURE SEALANTDenali CorporationEBC Pit and Fissure Sealant and Conditioner

Registered establishments

EstablishmentLocationWhat it does
GEORGE TAUB PRODUCTS & FUSION CO., INC.FDA reg. 2241860JERSEY CITY, NJ, United StatesManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 2241860). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.