Dental Device Guide
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Registered with FDA

Cosmedent, Inc.

Chicago, IL, United States. Lists 22 dental device types with FDA across 1 registered establishment, and holds 27 510(k) clearances as applicant.

FDA owner/operator1450653Repacker / relabeler2 clearances in five years
Device types listed
22
Brands and models
54
510(k) clearances
271986–2024
Markets registered in
933 registrations outside the US
Establishments
1United States
1986: 21987: 11989: 11990: 11992: 11993: 11998: 42000: 22002: 12004: 32005: 22006: 12007: 12009: 12017: 22021: 12022: 12024: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 9 markets

Where regulators' registries name Cosmedent, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 22 device types listedEuropean Union: 12 registrationsCanada: 6 registrationsBrazil: 5 registrationsSouth Korea: 3 registrationsAustralia: 2 registrationsCosta Rica: 2 registrationsIsrael: 2 registrationsTaiwan: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerCosmedent, Inc.27 clearances1986–2024Below
European UnionEUDAMEDManufacturerCosmedent, Inc.12—Pure Global AI
CanadaHealth CanadaRegistration holderCOSMEDENT, INC.62012–2014Pure Global AI
BrazilANVISAManufacturerCOSMEDENT INC.52009–2025Pure Global AI
South KoreaMFDSManufacturerCosmedent32026–2026Pure Global AI
AustraliaTGAManufacturerCosmedent Inc22004–2018Pure Global AI
Costa RicaMinisterio de SaludManufacturerCOSMEDENT, INC2—Pure Global AI
IsraelAMARManufacturerCOSMEDENT, INCCosmedent2—Pure Global AI
TaiwanTFDAManufacturerCosmedent12020–2020Pure 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 Cosmedent, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister
Brush and SculptBulkFillComplete Dual-Cure CatalystCosmeCoreCreative ColorRenamel Flowable MicrohybridRenamel GingafillRenamel MicrofillRenamel MicrohybridRenamel NANO
5 more
Renamel Posterior BodyRenamel Posterior OcclusalRenamel® De-Mark™Renamel® NANO™ +plusRSVP Light Body
2008
Dental CementEMA · Class 2Dental cementsLister
Complete Primer/Unfilled Resinda VinciE-Z TempInsureOxygonePrevueShow-Off
2008
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsLister
CosmeTempMirrorImageRSVP Heavy Body
2008
Resin Filling Material CoatingEBD · Class 2—Lister
GingaGuardRenamel Flowable MicrofillRenamel Flowable Microhybrid
2008
Impression MaterialELW · Class 2Impression materialsLister
ImpressivKwik
2008
Pit and Fissure Sealant and ConditionerEBC · Class 2Sealants & varnishesLister
CosmeSealPorcelEtch
2008
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisLister
EnamelizePorcelize
2008
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsLister
Complete Unfilled ResinSilanator
2006
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2—Lister
CompositeEtch
2008
Mercury and/or Alloy DispenserEHE · Class 1—Lister
Compule Gun
2020
Abrasive DiskEHJ · Class 1Polishing & prophylaxisLister
FlexiDiscFlexiWheel
2008
Prophylaxis CupEHK · Class 1Polishing & prophylaxisLister
FlexiCups
2008
Abrasive PointEHL · Class 1Polishing & prophylaxisLister
All Ceramic PolishersFlexiPointsMASS SPECTROMETRY MONITORING LINE CONONECTORS
2008
Polishing Agent StripEHM · Class 1Polishing & prophylaxisLister
FlexiStrip
2008
Preformed Impression TrayEHY · Class 1Impression traysLister
RSVP Impression Tray LowerRSVP Impression Tray Upper
2020
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsLister
Tips
2021
Dental Instrument HandleEJB · Class 1Dental hand instrumentsLister
Composite Pacement Instruments
2008
Polishing Agent WheelEJQ · Class 1Polishing & prophylaxisLister
Finishing Mandrels
2008
Matrix RetainerJEP · Class 1Dental hand instrumentsLister
Matrix Bands
2018
Resin ApplicatorKXR · Class 1—Lister
Cosmedent Brushes
2020
Cavity VarnishLBH · Class 2Sealants & varnishesLister
Desensitizer
2006
Dental Stain EraserMAU · Class 1—Lister
Cosmedent Easywhite
2022

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 Cosmedent, Inc. as the applicant.

Decided510(k)DeviceDevice type
24 Jul 2024K240714Insure® Universal; Insure® Universal AutomixEMA Dental Cement
11 Oct 2022K222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF Resin Tooth Shade Material
24 Jun 2021K211259Renamel BulkfillEBF Resin Tooth Shade Material
5 Dec 2017K172707Renamel MicrofillEBF Resin Tooth Shade Material
24 Feb 2017K163480Renamel NANO +plusEBF Resin Tooth Shade Material
20 Nov 2009K092730COSMEDENT BRUSHABLE COMPOSITEEBF Resin Tooth Shade Material
16 Apr 2007K070583NANO COMPOSITEEBF Resin Tooth Shade Material
16 May 2006K060881TEMPORARY CROWN & BRIDGE RESINEBG Resin Temporary Crown and Bridge
16 Dec 2005K052263MULTIPLE (TOOTH DESENSITIZER)LBH Cavity Varnish
21 Oct 2005K052501MULTIPLE RESIN TOOTH BONDING AGENTKLE Resin Tooth Bonding Agent
1 Dec 2004K042823COSMEDENT PIT & FISSURE SEALANTEBC Pit and Fissure Sealant and Conditioner
17 Jun 2004K041229MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)ELW Impression Material
3 Jun 2004K040994COSMEDENT CORE PASTEEBF Resin Tooth Shade Material
14 Feb 2002K011239GINDA GUARDEBD Resin Filling Material Coating
18 Jan 2000K993659RENAMEL PACKEBF Resin Tooth Shade Material
18 Jan 2000K993658RENAMEL SCULPTEBF Resin Tooth Shade Material
9 Nov 1998K980800LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALEBF Resin Tooth Shade Material
28 Oct 1998K980799HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALEBG Resin Temporary Crown and Bridge
9 Mar 1998K980298FLOWABLE HYBRIDEBD Resin Filling Material Coating
10 Feb 1998K974494RENAMEL FLOWABLE COMPOSITEEBD Resin Filling Material Coating
8 Jul 1993K924132E.Z. TEMEP, TEMPORARY FILLING MATERIALEMA Dental Cement
16 Jun 1992K921820RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATIONEBF Resin Tooth Shade Material
10 Jan 1990K894477INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEMEMA Dental Cement
24 Oct 1989K894994DENTIN BONDING SYSTEMKLE Resin Tooth Bonding Agent
29 Dec 1987K873356INSURE PORCELAIN VENEER BONDING SYSTEMEMA Dental Cement
12 Aug 1986K862912RENAMELIZE POLISHING PASTEEJR Oral Cavity Abrasive Polishing Agent
13 Mar 1986K854755RENAMEL ESTHETIC RESTORATIVE SYSTEMEBF Resin Tooth Shade Material

Some of these clearances are listed with FDA today by another company: Deltamed GmbH (15).

Also lists devices cleared under other names

Cosmedent, 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: S & C Polymer GmbH (3), Pulpdent Corporation (3), Silicon-Und Composite Spezialitaten GmbH (2), Gresco Products, Inc. (2), Denali Corporation (1), Millennium Dental International, Inc. (1), George Taub Products & Fusion Co., Inc. (1).

Decided510(k)DeviceApplicantDevice type
14 Mar 2014K132393CERCOM II CEMENTDenali CorporationEMA Dental Cement
25 Sep 2009K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANTS & C Polymer GmbHEMA Dental Cement
8 Nov 2005K053018POLY SILOXANE IMPRESSION MATERIALMillennium Dental International, Inc.ELW Impression Material
14 Feb 2001K010012LC PROVIFILLS & C Polymer GmbHEBG Resin Temporary Crown and Bridge
2 Nov 1999K992001TRAY-LINKSilicon-Und Composite Spezialitaten GmbHELW Impression Material
5 Jun 1998K973201PROVI CEMENTS & C Polymer GmbHEMA Dental Cement
17 Dec 1997K974014PULPDENT DENTASTIC UNOPulpdent CorporationEMA Dental Cement
18 Apr 1996K960938PROV-KBSilicon-Und Composite Spezialitaten GmbHEBG Resin Temporary Crown and Bridge
20 Apr 1993K930989PULPDENT UNFILLED DUAL CURE BONDING RESINPulpdent CorporationKLE Resin Tooth Bonding Agent
16 Mar 1993K926074PULPDENT DENTAL BOND ENCHANCERPulpdent CorporationEBF Resin Tooth Shade Material
15 Mar 1991K910803ENAMEL ETCHING GELGresco Products, Inc.DYH Resin Bracket and Tooth Conditioner Adhesive
4 Feb 1986K854588INSTA-GLAZEGeorge Taub Products & Fusion Co., Inc.EJR Oral Cavity Abrasive Polishing Agent
23 Dec 1985K854494CERAM-ETCHGresco Products, Inc.EBC Pit and Fissure Sealant and Conditioner

Registered establishments

EstablishmentLocationWhat it does
COSMEDENT, INC.FDA reg. 1450653CHICAGO, IL, United StatesRepacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1450653). 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.