Prosthetic devices · 21 CFR 872 Subpart D
Dental Cement
FDA device type “Cement, Dental”.
- Companies listing it
- 12069 makers
- Brands and models
- 633
- 510(k) clearances
- 50929 in five years
- FDA name
- Cement, Dental
510(k) clearances per year, 1976–2026
Companies that list EMA
120 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Barricaid Perio Dressing · Calibra Esthetic Resin Cement · Esthet-X Flow · Fluorocore II · +1 | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Cem | 15 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | EsCem · EsCem RMGI · EsTemp Implant · EsTemp NE · +2 | 22 | 2026 |
| Voco GmbH | Germany | Maker | Bifix Hybrid Abutment Cement · Bifix QM · Bifix SE · Bifix Temp · +15 | 117 | 2026 |
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | Dual Cure Resin Cement · TopCEM Ceramic Primer Ceramic Coupling Agent · TopCEM Dual Cure Resin Cement · TopCEM Vigor SA Self-Adhesive Resin Cement · +2 | 13 | 2025 |
| DiaDent Group International | South Korea | Maker | DIA-CEM | 24 | 2026 |
| Shofu Inc | Japan | Maker | AZ PRIMER · BEAUTICEM SA · BEAUTILINK SA · FL BOND II · +18 | 96 | 2025 |
| GC America Inc. | United States | Maker | BULK FujiCEM(AutoCompatible) · CAVITRON · Ceramic Primer · Ceramic Primer II · +77 | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Breeze · Breeze RMGI · Breeze Self-Adhesive Resin Cement · Cement-It · +17 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Clear Temp · DeOx · PermaShade LC Light Cure Veneer Cement · PermaShade Try-In Paste · +3 | 95 | 2026 |
| Prevest Denpro Limited | India | Maker | Micron Bioactive · Micron Dentin Conditioner · Micron Luting · Micron Superior Capsules Shade A1 · +5 | 7 | 2024 |
| Ivoclar Vivadent, AG | United States | Maker | Multilink Hybrid Abutment Test Pack · Multilink Primer A + B · Multilink Speed · SpeedCEM 100 · +3 | 94 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | CLEARFIL SE BOND 2 · PANAVIA 21 · PANAVIA F 2 · PANAVIA F 2 Complete Kit · +3 | 32 | 2025 |
| Inter-Med, Inc. | United States | Maker | Anchor · REGEN Bioactive Cement | 7 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | Metacem | 24 | 2024 |
| Shandong Huge Dental Material Corporation | China | Maker | Glass Ionomer Cement · Glass Ionomer Cement (Filling) · Glass Ionomer Cement (Luting) · TopCEM Dual Cure Resin Cement · +1 | 8 | 2026 |
| Deltamed GmbH | Germany | Maker | Insure® · Insure® Lite · Insure® Lite Automix · Insure® UNIVERSAL · +2 | 6 | 2024 |
| Premier Dental Products Company | United States | Maker | Premier Implant Cement · PREMIER TEMPORARY CEMENT · ZR-Cem | 28 | 2026 |
| Kettenbach GmbH & Co. KG | Germany | Maker | Visalys CemCore | 14 | 2026 |
| Sdi Limited | Australia | Maker | Everfix · riva · Riva Bond LC · Riva Cem Automix · +13 | 8 | 2022 |
| Bisco, Inc. | United States | Maker | BISCEM · Choice 2 DC · DUO-LINK · DUO-LINK UNIVERSAL · +8 | 88 | 2025 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | — | 20 | 2026 |
| Dentscare Ltda | Brazil | Maker | Allcem · Allcem Core | 10 | 2024 |
| Den-Mat Holdings, LLC | United States | Maker | Bio-Cap · Block-Out Try-In · Cling2® Resin Optimized Temporary Cement · Duo:PCH Cement · +9 | 8 | 2026 |
| Pac-Dent Inc. | United States | Maker | PacTemp Automix NE · PacTemp Automix NE Releasing Agent · PacTemp Automix Releasing Agent · Rodin Envision veneer cement · +1 | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | Nova 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 | 5 | 2022 |
| Keystone Industries | United States | Maker | Bosworth Zinc Phosphate Cement · Mizzy Fleck's Zinc Cement · Mizzy Polycarboxylate (PCA) Cement Powder · SuperEBA | 2 | 2025 |
| Detax GmbH | Germany | Maker | — | 2 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | Coltosol F · DUO TEMP · DuoCem · ParaCem Universal DC · +2 | 45 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | CEMPOWER · Flexi-Flow Auto E · Ti-Core Flow Plus, Ti-Core Auto E | 15 | 2023 |
| Dreve Dentamid GmbH | Germany | Maker | — | 6 | 2025 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Contax Intro + Activator · Contax Intro + Activator USA · Contax-Activator Refill · Contax-Bond Refill · +50 | 4 | 2022 |
| NuSmile, Ltd. | United States | Maker | NuSmile BioCem · NuSmile NuCem | 2 | 2026 |
| Overfibers S.R.L. | Italy | Maker | Neobond · OverCEM Cer-Abutment · OverCEM SA Opaque · OverCEM SA Translucent · +2 | 1 | 2025 |
| Pulpdent Corporation | United States | Maker | ACTIVA BioACTIVE BASE / LINER · ACTIVA BioACTIVE BULK FLOW · ACTIVA BioACTIVE CEMENT · ACTIVA BioACTIVE RESTORATIVE · +20 | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Bandtite · Cemper · Eugenone · Fastfil · +11 | 73 | 2020 |
| Reliance Orthodontic Products, Inc. | United States | Maker | GlassLok · Precedent | 32 | 2021 |
| Cavex Holland BV | Netherlands | Maker | Cavex Temporary Cement · Provisa Cem | 26 | 2015 |
| Sterngold | United States | Maker | SternOmega · Tempolock | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Tokuyama Dental Corporation | Japan | Maker | ESTECEM · ESTECEM II | 19 | 2021 |
| Septodont | France | Maker | — | 17 | 2021 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent Automix Dual Cure Luting Cement · Prime-Dent Dual Cure Luting Cement · Prime-Dent Glass Ionomer Cement · Prime-Dent Glass Ionomer Light Cured Restorative · +4 | 9 | 2012 |
| ITENA Clinical | France | Maker | CEMENT, DENTAL | 8 | 2017 |
| Micerium S.P.A. | Italy | Maker | ENA CEM · ENA CEM HF | 6 | 2011 |
| Psp Dental Co., Ltd. | United Kingdom | Maker | Carbchem, Zinc Phosphate · Ceram II Powder/Liquid · Ceramchem · Ceramcore · +11 | 6 | 1986 |
| Neodental Chemical Products Co., Ltd. | Japan | Maker | ENDODONTIC SEALER | 5 | 2011 |
| Silmet , Ltd. | Israel | Maker | GIC Filling · GIC Luting · Luting cem · ProBase · +11 | 3 | 2011 |
| Advanced Healthcare , Ltd. | United Kingdom | Maker | GlasIonomer Cement CX-Plus · Glass Ionomer Aesthetic Restorative · Glass Ionomer Luting Cement Radiopa · Glass Ionomer Silver Reinforced (Al · +5 | 3 | 2003 |
| Dental Technologies, Inc. | United States | Maker | Alpha-Dent Glass Ionomer Cement · Alpha-Dent Light Cure Band Adhesive · Alpha-Dent Polycarboxylate Cement · Alpha-TCem NE · +1 | 2 | 2013 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | — | 2 | 1986 |
| Temrex Corp. | United States | Maker | CR PLUS · DOC'S BEST RED COPPER CEMENT POWDER: DOC'S BEST UNIVERSAL LIQUID · DOC'S BEST WHITE COPPER CEMENT POWDER · INTERVAL · +6 | 2 | 2012 |
| Denali R & D Corporation | United States | Maker | AURA Cem · Aura Opaquer · AURA Veneer · Harmony · +1 | 2 | 2009 |
| Glustitch, Inc. | Canada | Maker | PeriAcryl®90 P-ACRYL2(C) · PeriAcryl®90 P-ACRYL2(V) · PeriAcryl®90 P-ACRYL5(C) · PeriAcryl®90 P-ACRYL5(V) · +6 | 2 | 2007 |
| Dfl Industria E Comercio SA | Brazil | Maker | Vitro Fil LC · Vitro Molar | 2 | 2013 |
| Sun Medical Co., Ltd. | Japan | Maker | iCEM Universal Plus | 2 | 2015 |
| Directa AB | Sweden | Maker | Ceramir Bioceramic Implant Cement QuikCap · Ceramir Crown & Bridge QuikCap · Ceramir Crown & Bridge QuikMix · Etchant Gel | 1 | 2015 |
| B.J.M. Laboratories Ltd | Israel | Maker | Activ GP · Cem-Implant · DentoCem · High-Q-Bond · +10 | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA DC Adhesive Luting · IDENTA Fast GIC Filling Molar · IDENTA GIC Filling Molar + Fast & Flow AC · IDENTA GIC Filling Molar + Regular AC · +5 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Viarden Lab LLC | United States | Maker | FEELING DUAL, FEELING CORE, DENT BOND · PCA CEMENT, IONGLASS, IONGLASS LUX | — | — |
| DOC BRANDS, Inc. | United States | Maker | Dentemp Recap-It · Recap-It · Refil-It | — | — |
| Hager & Werken | Germany | Maker | RESO PAC | — | — |
| Conamco | United States | Maker | Crushed Quartz · Medental | — | — |
| indigodental GmbH | Germany | Maker | PROVISA CEM TEMP CEM CLR SYR | — | — |
| Steiner Biotechnology LLC | United States | Maker | Oral Bond | — | — |
| Zinkh NV | Belgium | Maker | Elemental Granulate · Elemental PerioPlast | — | — |
| Ghimas SPA | Italy | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | BruxZir Dual Cure Resin Cement · Glidewell RMGI cement | 56 | 2026 |
| Kulzer, LLC | United States | Contract manufacturer | iCEM Universal Plus | 37 | 2026 |
| American Orthodontics | United States | Contract manufacturer | Bandtite Band Cement · Bandtite Glass Ionomer Cement | 44 | 2026 |
| Centrix, Inc. | United States | Contract manufacturer | Tempit Moisture Cure · Tempit-E | 44 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Complete Primer/Unfilled Resin · da Vinci · E-Z Temp · Insure · +3 | 27 | 2024 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | Glass-FX Bio · Glass-FX Clear · Glass-FX Conditioner · Glass-FX Micro | 2 | 2025 |
| Dent Zar, Inc. | United States | Repacker / relabeler | — | 12 | 1996 |
| Medental Intl. | United States | Repacker / relabeler | Medental | 7 | 1999 |
| Hager Worldwide, Inc. | United States | Manufacturer | Reso Pac | 2 | 2005 |
| Jersey Dental Supplies | United States | Repacker / relabeler | BIFIX QM · CALIBRA CEMENT · CEMENT, DENTAL · COE PAK AUTO MIX, REGULAR OR HARD SET · +32 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Cement Dental · Dental Cemenr · dental cement · Detnal cement · +5 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | dental composite, resin, cement | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Temporary Luting Cement | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Automix Dual Cure Luting Cement · Dual Cure Luting Cement · Glass Ionomer Cement; Glass Ionomer Restorative · Light Cure Glass Ionomer Restorative · +8 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Dental Cement · Fuji Lining · Maxcem · NX3 · +1 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Equia · Fuji Capsules · Fuji Cem · Fuji I · +9 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Durabond | — | — |
| Premium Plus Dental | United States | Lister | CEMENT , DENTAL | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DIA-CEM | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Fuji I · Fuji II · Fujicem Evolve · Implant Cement | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | MATERIAL, TOOTH SHADE, RESIN | — | — |
| Bina Limited | Belize | Foreign exporter | DENTAL CEMENT · SEALANT | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent | — | — |
| NU Radiance, Inc. | United States | Repacker / relabeler | Nu Tempcement | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | — | — | — |
| Signa Medical, Inc. | United States | Repacker / relabeler | Bio-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. | Canada | Foreign exporter | AH PLUS SEALER · KERR EWT SEALER | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | GC · 3M ESPE | — | — |
| Novocol Pharmaceutical of Canada, Inc. | Canada | Foreign exporter | Biodentine | — | — |
| Sanicure BV | Netherlands | Foreign exporter | CEMENT, DENTAL | — | — |
| Shenzhen Upcera Dental Technology Co., Ltd | China | Foreign exporter | EnduraCem; EsCem | — | — |
| Zapalign LLC | United States | Repacker / relabeler | CEMENT, DENTAL | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | CEMENT, DENTAL · PROVI CEMENT | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | MAXCEM 2 | — | — |
| Tender Corporation d/b/a Adventure Ready Brands | United States | Repacker / relabeler | CEMENT, DENTAL | — | — |
| Henry Schein Canada, Inc. | Canada | Foreign exporter | Solocem | — | — |
| HEXA Dental | United States | Contract manufacturer | Dental Cement | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| The Atlanta Dental supply Company | United States | Repacker / relabeler | — | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Frontier Dental Supply Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Pharmco Medical B.V. | Netherlands | Foreign exporter | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 25 Sep 2026 | K262983 | EsTemp Implant | Spident Co., Ltd. |
| 13 Aug 2026 | K254201 | Any-Cem | Mediclus Co., Ltd |
| 7 Aug 2026 | K261937 | PacTemp Automix NE | The Belport Company, Inc. DBA Gingi-Pak |
| 9 Jul 2026 | K261166 | DIA-CEM | DiaDent Group International |
| 18 May 2026 | K254109 | G-CEM UNIVERSAL | GC America Inc. |
| 15 Apr 2026 | K253337 | REGEN Bioactive Cement | Inter-Med, Inc. |
| 20 Mar 2026 | K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH |
| 19 Dec 2025 | K254063 | iCEM Universal Plus | Kulzer, LLC |
| 12 Dec 2025 | K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao HuGe Biomaterials Company, Ltd. |
| 9 Dec 2025 | K252808 | GlasIonomer FX-LC | Shofu Inc |
| 28 Oct 2025 | K252165 | ZIRCONOMER P | Shofu Inc |
| 19 Sep 2025 | K250953 | EQUIA LC ONE | GC America Inc. |
| 2 Sep 2025 | K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak |
| 11 Jul 2025 | K251470 | ResiCem EX | Shofu Inc |
| 11 Jul 2025 | K250156 | Choice 2 DC | Bisco, Inc. |
| 20 Jun 2025 | K250566 | EsCem RMGI | Spident Co., Ltd. |
| 10 Jan 2025 | K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. |
| 24 Jul 2024 | K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. |
| 28 Jun 2024 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao HuGe Biomaterials Company, Ltd. |
| 2 Apr 2024 | K240888 | Calibra Abutment Resin Cement | Dentsply Sirona, Inc. |
| 28 Sep 2023 | K233161 | BeautiLink SA | Shofu Inc |
| 28 Jul 2023 | K231552 | Dia-Cem | DiaDent Group International |
| 19 Dec 2022 | K214076 | EsCem | Spident Co., Ltd. |
| 22 Sep 2022 | K222253 | GlasIonomer FX ULTRA | Shofu Inc |
| 30 Aug 2022 | K214118 | Riva Cem Automix | Sdi Limited |
| 23 Aug 2022 | K220640 | Bifix Hybrid Abutment Cement | Voco GmbH |
| 9 Aug 2022 | K213609 | NOVA RESIN dual cure, self adhesive resin cement | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS |
| 1 Jun 2022 | K213201 | DeltaFil, DeltaFil Conditioner | DMG Chemisch-Pharmazeutische Fabrik GmbH |
| 20 Jan 2022 | K210259 | Parkell Self-Adhesive Cement | Parkell, Inc |
| 2 Nov 2021 | K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS |
| 13 Jul 2021 | K211237 | UltraTemp Rez II | Ultradent Products, Inc. |
| 11 Jun 2021 | K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. |
| 13 May 2021 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | Prevest Denpro Limited |
| 24 Nov 2020 | K200798 | G-CEM ONE | GC America Inc. |
| 13 Nov 2020 | K201937 | Ceramir Restore QuikCap | Doxa Dental AB |
| 29 Sep 2020 | K201790 | Dual Cure Resin Cement | Rizhao HuGe Biomaterials Company, Ltd. |
| 26 Aug 2020 | K201856 | Provicol QM Aesthetic | Voco GmbH |
| 21 Aug 2020 | K193260 | U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. |
| 2 Jul 2020 | K193484 | GC Fuji Triage EP | GC America Inc. |
| 17 Mar 2020 | K192007 | TheraBase, TheraBase Ca | Bisco, Inc. |
| 23 Jan 2020 | K192530 | Surefil one Self-adhesive Composite Hybrid | Dentsply Sirona, Inc. |
| 8 Nov 2019 | K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG |
| 5 Nov 2019 | K192992 | Suglue 3 | 3M Deutschland GmbH |
| 2 Nov 2019 | K183465 | Allcem, Allcem Core | Dentscare Ltda |
| 11 Oct 2019 | K191548 | Nexus Universal Self-Cure | Sybron Dental Specialties |
| 11 Jul 2019 | K182854 | GC FujiCEM 2 (Improved) | GC America Inc. |
| 29 May 2019 | K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 3M Espe Dental Products |
| 25 Apr 2019 | K183537 | PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. |
| 15 May 2018 | K171449 | Metacem | Meta Biomed Co, Ltd |
| 8 May 2018 | K180386 | Meron Plus QM | Voco GmbH |
| 2 Apr 2018 | K172382 | GC Fuji Direct | GC America Inc. |
| 14 Mar 2017 | K162960 | TotalC-Ram | ITENA Clinical |
| 3 Mar 2017 | K160345 | Glass Ionomer Cement | Shandong Huge Dental Material Corporation |
| 6 Feb 2017 | K170330 | 3M Protemp Cement Temporary Dental Cement | 3M Company |
| 16 Nov 2016 | K160800 | DuoCem | Coltene/Whaledent AG |
| 31 Oct 2016 | K161851 | Glass Ionomer Cement (Luting) | Shandong Huge Dental Material Corporation |
| 30 Sep 2016 | K160443 | TempoCem Clear | Dmg USA, Inc. |
| 3 Aug 2016 | K160774 | IonoStar Plus | Voco GmbH |
| 29 Jul 2016 | K161256 | TheraCem | Bisco, Inc. |
| 6 Jul 2016 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | GC America Inc. |
| 6 Jun 2016 | K142130 | ORAL BOND | Steiner Laboratories |
| 13 Apr 2016 | K153174 | Ketac Universal Aplicap | 3M Deutschland GmbH |
| 5 Apr 2016 | K152652 | PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement | Gaia Dental Products, Inc. |
| 25 Feb 2016 | K152691 | EDS Universal Cement | Essential Dental Systems, Inc. |
| 10 Sep 2015 | K151526 | Zone, ZoneFree, Zone A1 | Sybron Dental Specialties |
| 21 Aug 2015 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer | Kuraray Noritake Dental, Inc. |
| 17 Aug 2015 | K151332 | Nexus Universal, Nexus Universal Chroma | Sybron Dental Specialties |
| 22 Jul 2015 | K150601 | Zeramic Adhesive Resin Cement | Premier Dental Company Products |
| 17 Jun 2015 | K150727 | ESTECEM | Tokuyama Dental Corporation |
| 4 Jun 2015 | K142446 | Fixtemp Cement | Exacta Dental Direct, Inc. |
| 1 May 2015 | K143212 | Bifix Temp | Voco GmbH |
| 26 Feb 2015 | K142623 | PANAVIA SA Cement Plus Handmix | Kuraray Noritake Dental, Inc. |
| 27 Jan 2015 | K142625 | PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) | Kuraray Noritake Dental, Inc. |
| 10 Nov 2014 | K141503 | DENALI 501CEMENT | Denali Corporation |
| 20 Oct 2014 | K140993 | IONOSTAR MOLAR | Voco GmbH |
| 10 Jun 2014 | K134021 | ESTEMP IMPLANT, ESTEMP CLEAR | Spident Co., Ltd. |
| 14 Mar 2014 | K132393 | CERCOM II CEMENT | Denali Corporation |
| 24 Oct 2013 | K132255 | ULTRACEM | Ultradent Products Inc. / Oratech, LLC |
| 20 Aug 2013 | K130436 | MULTILINK HYBRID ABUTMENT CEMENT | Ivoclar Vivadent, AG |
| 14 Aug 2013 | K130421 | MERON APPLICATION CAPSULES | Voco GmbH |
| 14 Jun 2013 | K122551 | PROVITEMP | ITENA Clinical |
| 17 May 2013 | K122974 | TRYOUT-VPS HOLDING PASTE | Crown Delta Corp. |
| 26 Apr 2013 | K122549 | DENTO TEMP | ITENA Clinical |
| 19 Apr 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | ITENA Clinical |
| 29 Mar 2013 | K130223 | RMGI FILL | Pulpdent Corporation |
| 21 Feb 2013 | K123824 | VITRO FIL LC | Dfl Industria E Comercio SA |
| 19 Feb 2013 | K123595 | NEXUS RMGI | Sybron Dental Specialties |
| 14 Feb 2013 | K123826 | VITRO MOLAR | Dfl Industria E Comercio SA |
| 8 Jan 2013 | K121621 | SOLOCEM | Coltene/Whaledent AG |
| 7 Dec 2012 | K123273 | HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) | Temrex Corp. |
| 7 Dec 2012 | K123265 | RMGI LOW VISCOSITY | Pulpdent Corporation |
| 31 Jul 2012 | K120283 | DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT | Novocol, Inc. |
| 27 Jun 2012 | K120243 | GAM-200 | GC America Inc. |
| 18 Jun 2012 | K120159 | BEAUTICEM SA | Shofu Inc |
| 8 Jun 2012 | K120432 | TELIO CS CEM IMPLANT | Ivoclar Vivadent, AG |
| 30 Mar 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Kuraray Medical, Inc. |
| 30 Mar 2012 | K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S | Kuraray Medical, Inc. |
| 28 Mar 2012 | K112307 | RESIGLASS PASTE | Shofu Inc |
| 23 Jan 2012 | K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | Prime Dental Manufacturing, Inc. |
| 28 Dec 2011 | K113040 | CERAMIR CROWN & BRIDGE | Doxa Dental AB |
| 17 Nov 2011 | K111855 | HY-BOND RESIGLASS | Shofu Inc |
| 16 Sep 2011 | K111836 | PERMASHADE VENEER CEMENT | Ultradent Products, Inc. |
| 2 Sep 2011 | K111685 | IP TEMP CEMENT | Shofu Inc |
| 6 Jun 2011 | K111017 | CLEARTEMP | Ultradent Products, Inc. |
| 3 Jun 2011 | K110508 | SUGLUE-10 | 3M Espe AG |
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products |
| 4 Mar 2011 | K103585 | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP | Harry J. Bosworth Co. |
| 19 Nov 2010 | K102612 | VOCO IONOFIL MOLAR AC QUICK | Voco GmbH |
| 29 Oct 2010 | K101504 | TI-CORE FLOW | Essential Dental Systems, Inc. |
| 8 Oct 2010 | K101787 | DUOLINK II | Bisco, Inc. |
| 29 Sep 2010 | K101869 | PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) | Silmet , Ltd. |
| 17 Sep 2010 | K101420 | GC FUJI TEMP | GC America Inc. |
| 19 Aug 2010 | K101493 | ADVANCED GLASS IONOMER (K-130) RESTORATIVE | Dentsply International, Inc. |
| 23 Jul 2010 | K100247 | DETAX IMPLANTLINK SEMI | Detax GmbH & Co. KG |
| 22 Jun 2010 | K100908 | UNICEM HM | 3M Espe AG Dental Products |
| 10 Jun 2010 | K101044 | RETRIEVE IMPLANT CEMENT | Parkell, Inc |
| 2 Jun 2010 | K100756 | MALTA | 3M Espe AG Dental Products |
| 8 Apr 2010 | K094007 | UNICEM | 3M Espe AG Dental Products |
| 25 Mar 2010 | K100510 | CERAMIR CROWN & BRIDGE | Doxa AB |
| 17 Feb 2010 | K100290 | ESTEMP NE | Spident Co., Ltd. |
| 12 Feb 2010 | K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | Dmg USA, Inc. |
| 25 Sep 2009 | K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | S & C Polymer GmbH |
| 23 Jul 2009 | K090817 | IONOLUX | Voco GmbH |
| 17 Jun 2009 | K091106 | EQUIA | GC America Inc. |
| 4 Jun 2009 | K091019 | SPEEDCEM | Ivoclar Vivadent, AG |
| 2 Mar 2009 | K083766 | PHOGLASS CEM | S & C Polymer GmbH |
| 20 Feb 2009 | K083516 | PERIOGENIX | Oroscience, Inc. |
| 13 Feb 2009 | K083438 | BIFIX SE | Voco GmbH |
| 6 Feb 2009 | K083304 | TEMPOSIL 2 | Coltene/Whaledent AG |
| 26 Jan 2009 | K083398 | CERCOM CEMENT | Denali R & D Corporation |
| 15 Jan 2009 | K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | S & C Polymer GmbH |
| 25 Sep 2008 | K082449 | BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 | Bisco, Inc. |
| 5 Sep 2008 | K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER | Meta Biomed Co, Ltd |
| 5 Sep 2008 | K081702 | CARBOXYLATE CEM, PHOSPHATE CEM | S & C Polymer GmbH |
| 29 Aug 2008 | K081887 | LUTE-IT II VENEER CEMENT, MODEL NO6 | Pentron Clinical Technologies |
| 21 Aug 2008 | K081405 | XERACEM | Doxa Dental AB |
| 28 Jul 2008 | K081583 | CLEARFIL SA CEMENT | Kuraray Medical, Inc. |
| 11 Jun 2008 | K080517 | RESICEM | Shofu Inc |
| 11 Apr 2008 | K080768 | ULTRATEMP FIRM, FAST AND REGULAR SET | Ultradent Products, Inc. |
| 19 Mar 2008 | K073698 | SECURE | Parkell, Inc |
| 20 Feb 2008 | K073283 | GC GAM-100 | GC America Inc. |
| 23 Jan 2008 | K073173 | SELF-ADHESIVE RESIN CEMENT | Dentsply Interntional |
| 17 Jan 2008 | K073395 | GILB-2, GLASS IONOMER PROTECTIVE COATING | 3M Espe Dental Products |
| 17 Jan 2008 | K073101 | AURAVENEER CEMENT | Denali Corporation |
| 14 Dec 2007 | K073043 | SET PP | Sdi Limited |
| 16 Nov 2007 | K072604 | DUO TEMP | Coltene/Whaledent AG |
| 10 Oct 2007 | K071484 | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 | Glustitch, Inc. |
| 15 May 2007 | K070840 | GVC-100 | GC America Inc. |
| 26 Feb 2007 | K070319 | GC FUJI IX GP EXTRA | GC America Inc. |
| 12 Jan 2007 | K063554 | MERON PLUS | Voco GmbH |
| 27 Dec 2006 | K062355 | ENA CEM | Micerium S.P.A. |
| 15 Nov 2006 | K062065 | RIVA LUTING PLUS | Southern Dental Industries, Inc. |
| 9 Nov 2006 | K062064 | RIVA BOND LC | Southern Dental Industries, Inc. |
| 25 Oct 2006 | K062292 | UNICEM | 3M Espe Dental Products |
| 19 Oct 2006 | K062519 | NEXUS 3 | Sybron Dental Specialties |
| 26 Sep 2006 | K062410 | CLEARFIL ESTHETIC CEMENT & DC BOND | Kuraray Medical, Inc. |
| 5 Sep 2006 | K061781 | MULTILINK SPRINT | Ivoclar Vivadent, AG |
| 14 Jul 2006 | K061535 | GC XLC-100 CAPSULE | GC America Inc. |
| 15 May 2006 | K060701 | BISCEM TRANSLUCENT, BISCEM OPAQUE | Bisco, Inc. |
| 10 May 2006 | K060698 | CEMENT-IT ALL PURPOSE, MODEL N97 | Pentron Clinical Technologies |
| 2 May 2006 | K060894 | BIFIX QM | Voco GmbH |
| 23 Feb 2006 | K060334 | GI DENTSTAT | Ultradent Products, Inc. |
| 3 Feb 2006 | K053565 | TEMPBOND CLEAR WITH TRICLOSAN | Sybron Dental Specialties |
| 9 Nov 2005 | K053040 | PARACEM UNIVERSAL DC | Coltene/Whaledent AG |
| 27 Sep 2005 | K052235 | LCR | 3M Company |
| 7 Sep 2005 | K051952 | EUGENONE | Scientific Pharmaceuticals |
| 6 Sep 2005 | K051866 | PREMIER TEMPORARY CEMENT | Premier Dental Products Company |
| 22 Aug 2005 | K051427 | GC FUJI FIL LC | GC America Inc. |
| 15 Jun 2005 | K051008 | SET | Southern Dental Industries, Inc. |
| 3 Jun 2005 | K050870 | RIVA LIGHT CURE | Southern Dental Industries, Inc. |
| 27 May 2005 | K050658 | RESO-PAC PERIODONTAL DRESSING | Hager Worldwide, Inc. |
| 18 Mar 2005 | K050426 | TEMPOSIL, MODEL 6720 | Coltene/Whaledent AG |
| 20 Dec 2004 | K042846 | SYSTEMP.LINK | Ivoclar Vivadent, AG |
| 17 Dec 2004 | K042847 | SYSTEMP.CEM | Ivoclar Vivadent, AG |
| 7 Dec 2004 | K042452 | RIVA SILVER | Southern Dental Industries, Inc. |
| 20 Oct 2004 | K042669 | IONOFIL PLUS AC | Voco GmbH |
| 18 Oct 2004 | K041272 | DYRACT CEM PLUS CEMENT | Dentsply Intl., Inc. |
| 21 Sep 2004 | K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Premier Dental Products Company |
| 3 Aug 2004 | K040343 | TEMP F | Novocol, Inc. |
| 21 Jul 2004 | K041474 | MAXCEM | Sybron Dental Specialties |
| 16 Jun 2004 | K040906 | CALIBRA CEMENT | Dentsply Intl., Inc. |
| 21 May 2004 | K040895 | INTEGRITY TEMPORARY CEMENT | Dentsply Intl., Inc. |
| 30 Apr 2004 | K040393 | RIVA LUTING | Southern Dental Industries, Inc. |
| 20 Apr 2004 | K040236 | PULPDENT VLC RESIN CEMENT | Pulpdent Corporation |
| 26 Jan 2004 | K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | Premier Dental Products Company |
| 12 Nov 2003 | K031494 | DOC'S BEST WHITE COPPER CEMENT | Cooley & Cooley, Ltd. |
| 7 Nov 2003 | K032455 | PANAVIA F 2.0 | Kuraray Medical, Inc. |
| 5 Nov 2003 | K032470 | MULTILINK | Ivoclar Vivadent, AG |
| 4 Nov 2003 | K032597 | BISCEM GI | Bisco, Inc. |
| 31 Oct 2003 | K033068 | IONOFIL COLOR AC | Voco GmbH |
| 9 Oct 2003 | K032175 | DESENS-IONOMER | Milton Hodosh, M.D. |
| 5 Aug 2003 | K031752 | COLTOSOL F | Coltene/Whaledent AG |
| 17 Jul 2003 | K031467 | GLASIONOMER FX-II | Shofu Inc |
| 11 Jul 2003 | K031212 | TEMPORARY RESIN CEMENT | Parkell, Inc |
| 5 Jun 2003 | K030727 | POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT | Healex Products, Inc. |
| 17 Apr 2003 | K030516 | RIVA-SELF CURE | Southern Dental Industries, Inc. |
| 21 Mar 2003 | K030168 | AGC CEM | Wieland Dental + Technik GmbH & Co. KG |
| 21 Mar 2003 | K024287 | FIXOBRIDGE 3-CEMENT | Advanced Healthcare , Ltd. |
| 5 Mar 2003 | K023888 | CIMOFLUOR | Global Dental Products, Inc. |
| 31 Jan 2003 | K023981 | AHL GENERIC GLASS IONOMER LUTING CEMENT | Advanced Healthcare , Ltd. |
Showing the 200 most recent of 509.
Official records: FDA product classification for EMA · 21 CFR 872.3275.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026