Dental cements: manufacturers and brands

87 companies make or specify dental cements among the 149 that list one with FDA, under 739 brand and model names. FDA has issued 520 510(k) clearances in this category, 29 of them in the last five years.

1976: 21977: 61978: 41979: 41980: 91981: 91982: 51983: 61984: 61985: 51986: 101987: 81988: 181989: 91990: 231991: 101992: 141993: 151994: 221995: 201996: 131997: 161998: 281999: 112000: 102001: 212002: 102003: 172004: 132005: 92006: 132007: 62008: 142009: 102010: 142011: 92012: 112013: 122014: 42015: 92016: 112017: 32018: 32019: 72020: 82021: 42022: 72023: 22024: 32025: 102026: 719801990200020102020

510(k) clearances per year, 1976–2026

Dental cement manufacturers

Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerBarricaid Perio Dressing · Calibra Esthetic Resin Cement · Esthet-X Flow · Fluorocore II · +11482026
Mediclus Co., LtdSouth KoreaMakerAny-Cem · Any-Temp Eugenol152026
Spident Co., Ltd.South KoreaMakerEsCem · EsCem RMGI · EsTemp Implant · EsTemp NE · +2222026
Voco GmbHGermanyMakerBifix Hybrid Abutment Cement · Bifix QM · Bifix SE · Bifix Temp · +161172026
Rizhao HuGe Biomaterials Company, Ltd.ChinaMakerDual Cure Resin Cement · TopCEM Ceramic Primer Ceramic Coupling Agent · TopCEM Dual Cure Resin Cement · TopCEM Vigor SA Self-Adhesive Resin Cement · +2132025
DiaDent Group InternationalSouth KoreaMakerDIA-CEM · DIACEM TEMPNE242026
Shofu IncJapanMakerAZ PRIMER · BEAUTICEM SA · BEAUTILINK SA · FL BOND II · +18962025
GC America Inc.United StatesMakerBULK FujiCEM(AutoCompatible) · CAVITRON · Ceramic Primer · Ceramic Primer II · +771372026
Sybron Dental SpecialtiesUnited StatesMakerBreeze · Breeze RMGI · Breeze Self-Adhesive Resin Cement · Cement-It · +192032026
Ultradent Products, Inc.United StatesMakerClear Temp · DeOx · PermaShade LC Light Cure Veneer Cement · PermaShade Try-In Paste · +3952026
Prevest Denpro LimitedIndiaMakerMicron Bioactive · Micron Dentin Conditioner · Micron Luting · Micron Superior Capsules Shade A1 · +872024
Ivoclar Vivadent, AGUnited StatesMakerMultilink Hybrid Abutment Test Pack · Multilink Primer A + B · Multilink Speed · SpeedCEM 100 · +3942026
Kuraray Noritake Dental, Inc.JapanMakerCLEARFIL SE BOND 2 · PANAVIA 21 · PANAVIA F 2 · PANAVIA F 2 Complete Kit · +3322025
Inter-Med, Inc.United StatesMakerAnchor · REGEN Bioactive Cement72026
Meta Biomed Co, LtdUnited StatesMakerMetacem242024
Shandong Huge Dental Material CorporationChinaMakerGlass Ionomer Cement · Glass Ionomer Cement (Filling) · Glass Ionomer Cement (Luting) · TopCEM Dual Cure Resin Cement · +182026
Deltamed GmbHGermanyMakerInsure® · Insure® Lite · Insure® Lite Automix · Insure® UNIVERSAL · +262024
Premier Dental Products CompanyUnited StatesMakerPremier Implant Cement · PREMIER TEMPORARY CEMENT · ZR-Cem282026
Kettenbach GmbH & Co. KGGermanyMakerVisalys CemCore142026
Sdi LimitedAustraliaMakerEverfix · riva · Riva Bond LC · Riva Cem Automix · +1382022
Bisco, Inc.United StatesMakerBISCEM · Choice 2 DC · DUO-LINK · DUO-LINK UNIVERSAL · +8882025
Parkell, IncUnited StatesMaker—582025
Vericom Co., Ltd.South KoreaMaker—202026
Dentscare LtdaBrazilMakerAllcem · Allcem Core102024
Den-Mat Holdings, LLCUnited StatesMakerBio-Cap · Block-Out Try-In · Cling2® Resin Optimized Temporary Cement · Duo:PCH Cement · +982026
Pac-Dent Inc.United StatesMakerPacTemp Automix NE · PacTemp™ Automix NE Releasing Agent · PacTemp™ Automix Releasing Agent · Rodin Envision veneer cement · +252022
Imicryl Dis Malzemeleri Sanayi VE Ticaret ASTürkiyeMakerNova Aqua GIL, Nova Aqua GIF · Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus, Nova Glass GL) · Nova Glass II F, Nova Glass II LC, Fissured II Nova · Nova Resin Cement · +152022
Keystone IndustriesUnited StatesMakerBosworth Zinc Phosphate Cement · Mizzy Fleck's Zinc Cement · Mizzy Polycarboxylate (PCA) Cement Powder · SuperEBA · +322025
Detax GmbHGermanyMaker—22025
Coltene/Whaledent AGSwitzerlandMakerColtosol F · DUO TEMP · DuoCem · ParaCem Universal DC · +2452022
J. Morita USA, Inc.United StatesMakerPower Temp(TM) Temporary Cement422022
Essential Dental Systems, Inc.United StatesMakerCEMPOWER · Flexi-Flow Auto E · Ti-Core Flow Plus, Ti-Core Auto E152023
Dreve Dentamid GmbHGermanyMaker—62025
DMG Chemisch-Pharmazeutische Fabrik GmbHGermanyMakerContax Intro + Activator · Contax Intro + Activator USA · Contax-Activator Refill · Contax-Bond Refill · +5242022
NuSmile, Ltd.United StatesMakerNuSmile BioCem · NuSmile NuCem22026
Overfibers S.R.L.ItalyMakerNeobond · OverCEM Cer-Abutment · OverCEM SA Opaque · OverCEM SA Translucent · +212025
Pulpdent CorporationUnited StatesMakerACTIVA BioACTIVE BASE / LINER · ACTIVA BioACTIVE BULK FLOW · ACTIVA BioACTIVE CEMENT · ACTIVA BioACTIVE RESTORATIVE · +221072021
Scientific PharmaceuticalsUnited StatesMakerBandtite · Cemper · Eugenone · Fastfil · +13732020
Reliance Orthodontic Products, Inc.United StatesMakerGlassLok · Precedent322021
Cavex Holland BVNetherlandsMakerCavex Temporary Cement · Provisa Cem262015
SterngoldUnited StatesMakerSternOmega · Tempolock242017
S & C Polymer GmbHGermanyMaker—202009
Tokuyama Dental CorporationJapanMakerESTECEM · ESTECEM II192021
SeptodontFranceMaker—172021
Prime Dental Manufacturing, Inc.United StatesMakerPrime-Dent Automix Dual Cure Luting Cement · Prime-Dent Dual Cure Luting Cement · Prime-Dent Glass Ionomer Cement · Prime-Dent Glass Ionomer Light Cured Restorative · +792012
ITENA ClinicalFranceMakerCEMENT, DENTAL82017
Micerium S.P.A.ItalyMakerENA CEM · ENA CEM HF62011
Psp Dental Co., Ltd.United KingdomMakerCarbchem, Zinc Phosphate · Ceram II Powder/Liquid · Ceramchem · Ceramcore · +1261986
Neodental Chemical Products Co., Ltd.JapanMakerENDODONTIC SEALER52011
Silmet , Ltd.IsraelMakerGIC Filling · GIC Luting · Luting cem · ProBase · +1232011
Advanced Healthcare , Ltd.United KingdomMakerGlasIonomer Cement CX-Plus · Glass Ionomer Aesthetic Restorative · Glass Ionomer Luting Cement Radiopa · Glass Ionomer Silver Reinforced (Al · +732003
Dental Technologies, Inc.United StatesMakerAlpha-Dent Glass Ionomer Cement · Alpha-Dent Light Cure Band Adhesive · Alpha-Dent Polycarboxylate Cement · Alpha-TCem NE · +122013
George Taub Products & Fusion Co., Inc.United StatesMaker—21986
Temrex Corp.United StatesMakerCR PLUS · DOC'S BEST RED COPPER CEMENT POWDER: DOC'S BEST UNIVERSAL LIQUID · DOC'S BEST WHITE COPPER CEMENT POWDER · INTERVAL · +622012
Denali R & D CorporationUnited StatesMakerAURA Cem · Aura Opaquer · AURA Veneer · Harmony · +122009
Glustitch, Inc.CanadaMakerPeriAcryl®90 P-ACRYL2(C) · PeriAcryl®90 P-ACRYL2(V) · PeriAcryl®90 P-ACRYL5(C) · PeriAcryl®90 P-ACRYL5(V) · +622007
Dfl Industria E Comercio SABrazilMakerVitro Fil LC · Vitro Molar22013
Sun Medical Co., Ltd.JapanMakeriCEM Universal Plus22015
Directa ABSwedenMakerCeramir Bioceramic Implant Cement QuikCap · Ceramir Crown & Bridge QuikCap · Ceramir Crown & Bridge QuikMix · Etchant Gel12015
Prestige Brands Holdings, Inc.United StatesMakerDentek Complete Dental Repair Kit · Dentek Dental First Aid Kit · Temparin Max Hold · Thin Set Cap and Crown Cement12013
Seilglobal CO., LtdSouth KoreaMakerZirADD12015
Aspen Surgical ProductsUnited StatesMakerSymmetry Surgical——
B.J.M. Laboratories LtdIsraelMakerActiv GP · Cem-Implant · DentoCem · High-Q-Bond · +10——
ZOGEAR Medical Co., Ltd.ChinaMakerZINC OXIDE EUGENOL——
Identa Dental Material GmbHGermanyMakerIDENTA DC Adhesive Luting · IDENTA Fast GIC Filling Molar · IDENTA GIC Filling Molar + Fast & Flow AC · IDENTA GIC Filling Molar + Regular AC · +5——
Solventum US LLCUnited StatesMaker———
KI. Works Vietnam Co., Ltd.VietnamMakerCVS FLNG CRWN RPR 1CT - 695108 · CVS LST FL CR RPR 2CT - 572123——
Nanchang White Technology Co., Ltd.ChinaMakerZinc Oxide Eugenol——
Produits Dentaires SASwitzerlandMakerEssenSeal · Eugenol · Zinc Oxide——
Associated Dental Products LtdUnited KingdomMakerAlganol Liquid 30ml · Alganol Powder 90g · Eugenol B.P. Liquid 150ml · Eugenol B.P. Liquid 30ml · +6——
Aadi Med Private LimitedIndiaMakerZOE Impression Paste, Zinc Oxide Powder, Eugenol, Ziego——
Maquira Industria de Produtos OdontologicosBrazilMakerFill Canal · Provisory Temporary Cement · Surgical Cement——
Viarden Lab LLCUnited StatesMakerFEELING DUAL, FEELING CORE, DENT BOND · PCA CEMENT, IONGLASS, IONGLASS LUX · CRI INTERMEDIAL CEMENT VIARDEN LAB, VIAR PACK VIARDEN LAB · EUGENOL LIQUID VIARDEN LAB · +1——
DOC BRANDS, Inc.United StatesMakerDentemp Recap-It · Recap-It · Refil-It · Dental Cement · +2——
Hager & WerkenGermanyMakerRESO PAC——
Nobil Metal S p AItalyMakerNOBIL FIX · NOBIL GRIP——
Changsha Easyinsmile Intelligence Technology Co.,Ltd.ChinaMakerX-root Sealer Dental cement——
SKY DENT Corp for dental tradingUnited StatesMakerSKY DENT TEMPORARY FILLING - 1DERFUL TEMPORARY FILLING——
ConamcoUnited StatesMakerCrushed Quartz · Medental——
Global Dent Aids Pvt. Ltd.IndiaMakerDENTEMP——
indigodental GmbHGermanyMakerPROVISA CEM TEMP CEM CLR SYR——
Steiner Biotechnology LLCUnited StatesMakerOral Bond——
ChangShu ShangChi Dental Materials Co., Ltd.ChinaMakerZinc Oxide Eugenol Cement——
Zinkh NVBelgiumMakerElemental Granulate · Elemental PerioPlast——
Shanghai Rong Xiang Dental Material Company LimitedChinaMakerM3 Naturals Ventures, LLC · NK——
Iimed Medical Mexicana S. de R.L. de C.V.MexicoMakerSUB1 TEMP MAX 2.64——
Ghimas SPAItalyMaker———
Prismatik Dentalcraft, Inc.United StatesContract manufacturerBruxZir™ Dual Cure Resin Cement · Glidewell RMGI cement562026
Kulzer, LLCUnited StatesContract manufactureriCEM Universal Plus372026
American OrthodonticsUnited StatesContract manufacturerBandtite™ Band Cement · Bandtite Glass Ionomer Cement442026
Centrix, Inc.United StatesContract manufacturerTempit Moisture Cure · Tempit-E442025
Cosmedent, Inc.United StatesRepacker / relabelerComplete Primer/Unfilled Resin · da Vinci · E-Z Temp · Insure · +3272024
DSI Dental Solutions LtdIsraelManufacturerGlass-FX Bio · Glass-FX Clear · Glass-FX Conditioner · Glass-FX Micro · +222025
Dent Zar, Inc.United StatesRepacker / relabeler—121996
Medental Intl.United StatesRepacker / relabelerMedental71999
Integra LifeSciences CorporationUnited StatesContract manufacturerMiltex22014
Hager Worldwide, Inc.United StatesManufacturerReso Pac22005
Dharma Research, Inc.United StatesContract manufacturerADS Calcium Hydroxide · ADS Eugenol · ADS Zinc Oxide · Dharma Calcium Hydroxide · +512015
Wuxi Lyusmile Imp and Exp Co.,ltdChinaPrivate-label distributorEUGENOL · ZINC OXIDE EUGENOL——
Jersey Dental SuppliesUnited StatesRepacker / relabelerBIFIX QM · CALIBRA CEMENT · CEMENT, DENTAL · COE PAK AUTO MIX, REGULAR OR HARD SET · +33——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerANGELUS——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerCement Dental · Dental Cemenr · dental cement · Detnal cement · +5——
Jmu Dental, Inc.United StatesRepacker / relabelerdental composite, resin, cement——
Patterson Companies, Inc.United StatesForeign exporterPatterson Temporary Luting Cement · Patterson® Zinc Cement——
Ortho Pro Dent LLCUnited StatesRepacker / relabelerAutomix Dual Cure Luting Cement · Dual Cure Luting Cement · Glass Ionomer Cement; Glass Ionomer Restorative · Light Cure Glass Ionomer Restorative · +8——
Soher Med LimitedHong Kong SAR ChinaForeign exporterDental Cement · Fuji Lining · Maxcem · NX3 · +1——
Samtrade Supplies Inc.CanadaForeign exporterEquia · Fuji Capsules · Fuji Cem · Fuji I · +10——
International Orthodontics Services. PCUnited StatesRepacker / relabelerDurabond——
Premium Plus DentalUnited StatesListerCEMENT , DENTAL——
Diadent Group Intl., Inc.CanadaForeign exporterDIA-CEM · DiaCemTempNE——
CARGUS International Inc.United StatesRepacker / relabeler———
LLD Care d.o.o.CroatiaForeign exporterFuji I · Fuji II · Fujicem Evolve · Implant Cement——
First Dental Supplies LLCUnited StatesRepacker / relabelerMATERIAL, TOOTH SHADE, RESIN——
Ortho Solutions LCUnited StatesContract manufacturer———
Bina LimitedBelizeForeign exporterDENTAL CEMENT · SEALANT——
Lena Ko CorporationTaiwanForeign exporterCVS FLNG CRWN RPR 1CT - 695108 · CVS LST FL CR RPR 2CT - 572123——
Dentonics IncUnited StatesRepacker / relabelerMaster-Dent——
NU Radiance, Inc.United StatesRepacker / relabelerNu Tempcement——
Axiodent Inc.United StatesRepacker / relabelerAxioIRM · AxioIRM XS · AxioZi-Temp——
Signa Medical, Inc.United StatesRepacker / relabelerBio-Cap; Block-Out Try-In; Duo PCH; Duo:PCH Cement; Geristore; GoldLink 2; Holistore; Infinity; Infinity SE; Lumineers · CEMENT, DENTAL——
E/T Endodontic Technologies, Ltd.CanadaForeign exporterAH PLUS SEALER · KERR EWT SEALER——
HI Medical Co., Ltd.South KoreaForeign exporterGC · 3M ESPE——
Novocol Pharmaceutical of Canada, Inc.CanadaForeign exporterBiodentine——
Sanicure BVNetherlandsForeign exporterCEMENT, DENTAL——
Shenzhen Upcera Dental Technology Co., LtdChinaForeign exporterEnduraCem; EsCem——
Zapalign LLCUnited StatesRepacker / relabelerCEMENT, DENTAL · ZINC OXIDE EUGENOL——
Diverge Group IncHong Kong SAR ChinaForeign exporter———
Ki. WORKS VIETNAM CO., LTDHong Kong SAR ChinaForeign exporter———
Zapalign Inc.South KoreaForeign exporterCEMENT, DENTAL · PROVI CEMENT · ZINC OXIDE EUGENOL——
Steel City Health Private LimitedIndiaRepacker / relabelerCavity Filler for Crowns & Bridge Work · Crowns, Fillings & Bridges · Cureforte - Dental Cement Kit – Zinc Oxide Eugenol · Emergency Dental Care set · +3——
Prais Reliable Dental Supplies S.ASeychellesForeign exporterMAXCEM 2——
Tender Corporation d/b/a Adventure Ready BrandsUnited StatesRepacker / relabelerCEMENT, DENTAL——
Henry Schein Canada, Inc.CanadaForeign exporterSolocem——
HEXA DentalUnited StatesContract manufacturerDental Cement——
Opa Dental, LLCUnited StatesRepacker / relabeler———
Kash Sales Inc.CanadaForeign exporter———
Jack Jack LLCUnited StatesListerJJ CARE Temporary Tooth Cement, Zinc Eugenol Powder & Liquid, Eugenol Cement, Zinc Oxide Eugenol——
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
Indivation Exports Private LimitedIndiaRepacker / relabelerMastermedi Zinc Oxide Eugenol Cement Dental Care Kit——
The Atlanta Dental supply CompanyUnited StatesRepacker / relabeler———
Dylan Lucas International IncCanadaForeign exporter———
Frontier Dental Supply IncCanadaForeign exporter———
Mainline Medical Dental SupplyCanadaForeign exporter———
MHM Grupo Diamante, S.A. de C.V.MexicoForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Pharmco Medical B.V.NetherlandsForeign exporter———
Tas Medical SupplyUnited StatesForeign exporter———
Worldwide Supplies LimitedHong Kong SAR ChinaForeign exporter———
Zircon Plus LimitedIsraelForeign exporter———

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

Where dental cements are made

Number of makers in this category with a manufacturing establishment in the country.

FDA device types in this category

Device typeClassRegulationMakersClearances
Dental CementEMA2872.327569509
Zinc Oxide EugenolEMB1872.32753811

Recent clearances

Decided510(k)DeviceApplicantDevice type
25 Sep 2026K262983EsTemp ImplantSpident Co., Ltd.EMA Dental Cement
13 Aug 2026K254201Any-CemMediclus Co., LtdEMA Dental Cement
7 Aug 2026K261937PacTemp Automix NEThe Belport Company, Inc. DBA Gingi-PakEMA Dental Cement
9 Jul 2026K261166DIA-CEMDiaDent Group InternationalEMA Dental Cement
18 May 2026K254109G-CEM UNIVERSALGC America Inc.EMA Dental Cement
15 Apr 2026K253337REGEN Bioactive CementInter-Med, Inc.EMA Dental Cement
20 Mar 2026K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbHEMA Dental Cement
19 Dec 2025K254063iCEM Universal PlusKulzer, LLCEMA Dental Cement
12 Dec 2025K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao HuGe Biomaterials Company, Ltd.EMA Dental Cement
9 Dec 2025K252808GlasIonomer FX-LCShofu IncEMA Dental Cement
28 Oct 2025K252165ZIRCONOMER PShofu IncEMA Dental Cement
19 Sep 2025K250953EQUIA LC ONEGC America Inc.EMA Dental Cement
2 Sep 2025K251775RODIN CementBelport Company, Inc., Gingi-PakEMA Dental Cement
11 Jul 2025K251470ResiCem EXShofu IncEMA Dental Cement
11 Jul 2025K250156Choice 2 DCBisco, Inc.EMA Dental Cement
20 Jun 2025K250566EsCem RMGISpident Co., Ltd.EMA Dental Cement
10 Jan 2025K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-AbutmentOverfibers S.R.L.EMA Dental Cement
24 Jul 2024K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc.EMA Dental Cement
28 Jun 2024K241204TopCEM-Veneer Light Cure Veneer CementRizhao HuGe Biomaterials Company, Ltd.EMA Dental Cement
2 Apr 2024K240888Calibra Abutment Resin CementDentsply Sirona, Inc.EMA Dental Cement
28 Sep 2023K233161BeautiLink SAShofu IncEMA Dental Cement
28 Jul 2023K231552Dia-CemDiaDent Group InternationalEMA Dental Cement
19 Dec 2022K214076EsCemSpident Co., Ltd.EMA Dental Cement
22 Sep 2022K222253GlasIonomer FX ULTRAShofu IncEMA Dental Cement
30 Aug 2022K214118Riva Cem AutomixSdi LimitedEMA Dental Cement
23 Aug 2022K220640Bifix Hybrid Abutment CementVoco GmbHEMA Dental Cement
9 Aug 2022K213609NOVA RESIN dual cure, self adhesive resin cementImicryl Dis Malzemeleri Sanayi VE Ticaret ASEMA Dental Cement
1 Jun 2022K213201DeltaFil, DeltaFil ConditionerDMG Chemisch-Pharmazeutische Fabrik GmbHEMA Dental Cement
20 Jan 2022K210259Parkell Self-Adhesive CementParkell, IncEMA Dental Cement
2 Nov 2021K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)Imicryl Dis Malzemeleri Sanayi VE Ticaret ASEMA Dental Cement
13 Jul 2021K211237UltraTemp Rez IIUltradent Products, Inc.EMA Dental Cement
11 Jun 2021K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc.EMA Dental Cement
13 May 2021K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)Prevest Denpro LimitedEMA Dental Cement
24 Nov 2020K200798G-CEM ONEGC America Inc.EMA Dental Cement
13 Nov 2020K201937Ceramir Restore QuikCapDoxa Dental ABEMA Dental Cement
29 Sep 2020K201790Dual Cure Resin CementRizhao HuGe Biomaterials Company, Ltd.EMA Dental Cement
26 Aug 2020K201856Provicol QM AestheticVoco GmbHEMA Dental Cement
21 Aug 2020K193260U-Cem Premium & MAZIC CemVericom Co., Ltd.EMA Dental Cement
2 Jul 2020K193484GC Fuji Triage EPGC America Inc.EMA Dental Cement
17 Mar 2020K192007TheraBase, TheraBase CaBisco, Inc.EMA Dental Cement