Root canal filling materials: manufacturers and brands
132 companies make or specify root canal filling materials among the 189 that list one with FDA, under 889 brand and model names. FDA has issued 213 510(k) clearances in this category, 33 of them in the last five years.
510(k) clearances per year, 1976–2026
Root canal filling material 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.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | EUROPOST · EXCELPOST · FIBIO · FLEXI-POSTS | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | ProRoot MTA · ProRoot MTA Matl (root repair) · ProRoot MTA, Tooth Colored Formula · Root Canal Lube · +2 | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Paste · BLSEAL · BLSEAL Putty · CanalPro CalciSeal · +3 | 15 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | VioSeal · Vioseal X · Gutta Percha · GUTTA PERCHA POINTS · +3 | 22 | 2026 |
| Voco GmbH | Germany | Maker | Rebilda Post · Rebilda Post GT · MTA vpt | 117 | 2026 |
| DiaDent Group International | South Korea | Maker | DIA-PROSEAL · DIA-ROOT BIO MTA · DIA-ROOT BIO Sealer · DiaPaste · +4 | 24 | 2026 |
| GC America Inc. | United States | Maker | EVERSTICK POST · GC Fiber Post · Nogenol Root Canal Sealer | 137 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | Pulp Canal Sealer · Pulp Canal Sealer EWT · Sealapex · Sealapex Xpress · +36 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | EndoREZ Accelerator · EndoREZ Dual Cure · EndoREZ Obturation Kit · MTApex Bioceramic Root Canal Sealer · +5 | 95 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | MTA1 | 23 | 2025 |
| Prevest Denpro Limited | India | Maker | CalApex · Calplus · Cerafill RCS · Endoseal · +3 | 7 | 2024 |
| Inter-Med, Inc. | United States | Maker | RE-GEN Bioactive Endosealer · REGEN Bioactive EndoPutty · Vista-Cal | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | ParaPost Fiber Lux · ParaPost Fiber White · ParaPost Taper Lux | 5 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | ADSEAL · ADSEAL Plus · CeraPutty · CeraSeal · +11 | 24 | 2024 |
| Premier Dental Products Company | United States | Maker | Premier Absorbent Points · INTEGRA POST | 28 | 2026 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | Calcium Hydroxide Temporary Filling Material (KP-Cal ) · Injectable Root Canal Sealer (KP-Root SP) · Gutta Percha Points and Bar | 3 | 2026 |
| Parkell, Inc | United States | Maker | Resin post | 58 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | Well-Paste · Well-Pex | 20 | 2026 |
| Dentscare Ltda | Brazil | Maker | Whitepost DC · Whitepost DC-E · Whitepost System DC FIT Intro · Whitepost System DC FIT Refill · +9 | 10 | 2024 |
| Innovative Bioceramix, Inc. | Canada | Maker | EdgeBioceramic RetroFill and Perforation Repair Material .5g · EdgeBioceramic Sealer 2g · EdgeBioceramic ThermalFlow 1.5g · EndoSequence BC Pediatric Putty .5g 1P · +18 | 8 | 2023 |
| Pac-Dent Inc. | United States | Maker | JS Dental | 5 | 2022 |
| Beijing C-Root Dental Medical Devices Co., LTD. | China | Maker | C-Root BP · Injectable Root Canal Bioceramic Sealer | 2 | 2024 |
| Enpuno Biotechnology Co., Ltd | China | Maker | Injectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5 · Root canal repair materials (nRoot BP) | 2 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | Fiber Lux Plus · ParaPost Fiber Lux® · PARAPOST FIBER WHITE · ParaPost Fiber White Plus · +8 | 45 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | BioSeal · EZ-Fill Bi-Directional Spiral · EZ-Fill Cement · EZ-Fill Root Canal Cement · +4 | 15 | 2023 |
| Maruchi | South Korea | Maker | AH Plus® Bioceramic Sealer · CleaniCal · ENDOCEM MTA · ENDOCEM MTA PREMIXED REGULAR · +6 | 8 | 2023 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | LuxaPost PS Intro USA · LuxaPost PS Refill 1.25 USA · LuxaPost PS Refill 1.375 USA · LuxaPost PS Refill 1.5 USA | 4 | 2022 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Gutta Percha, Gutta Cutter | 4 | 2022 |
| NuSmile, Ltd. | United States | Maker | Avalon Biomed Grey MTA Plus · Avalon Biomed NeoMTA 2 · Avalon Biomed NeoMTA Plus · Avalon Biomed NeoPUTTY · +29 | 2 | 2026 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Gutta Percha Cutter, Gutta Percha Obturator · Absorbent Paper Points · Fibre Post, Dental Screw Post, Orthodontic Microimplant | 1 | 2025 |
| Overfibers S.R.L. | Italy | Maker | Conical Over Post # Large · Conical Over Post # Medium · Conical Over Post # Small · Cylindrical Over Post # 0,8 · +43 | 1 | 2025 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Fliex · NIC · ROOT.X · SUPERFILE | 1 | 2025 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | Gutta Percha Points, Injectable Root Canal Sealer · Absorbent Paper Points | 1 | 2023 |
| Odne AG | Switzerland | Maker | OdneFill | 1 | 2024 |
| Sprig Oral Health Technologies, Inc. | United States | Maker | SmartMTA Capsule | 1 | 2023 |
| Pulpdent Corporation | United States | Maker | Forendo · Pulpdent Root Canal Sealer Kit · Pulpdent Root Canal Sealer Liquid · Pulpdent Root Canal Sealer Powder | 107 | 2021 |
| Sterngold | United States | Maker | Stern Root Anchor System | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Aseptico, Inc. | United States | Maker | BNSG1QA0025G Gutta-Smart GP Crtg 25G-10 Pack · BNSGS1QA0020G Gutta-Smart GP Crtg 20G 10-Pack · BNSGS1QA0023G Gutta-Smart GP Crtg 23G-10 Pack · GP-018CP-DS - GUTTA PERCHA 18 PACKAGED CARTRIDGE FOR AEU-65-DS · +18 | 17 | 2015 |
| Septodont | France | Maker | — | 17 | 2021 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | BIO-C REPAIR · BIO-C REPAIR ION+ · Bio-C Sealer · BIO-C SEALER ION+ · +19 | 11 | 2021 |
| ITENA Clinical | France | Maker | RESIN, ROOT CANAL FILLING · ROOT CANAL | 8 | 2017 |
| SWEDEN & MARTINA S.p.A. | Italy | Maker | STARTER PACK | 6 | 2019 |
| Micerium S.P.A. | Italy | Maker | ENA POST | 6 | 2011 |
| Neodental Chemical Products Co., Ltd. | Japan | Maker | Root Canal Medicament · Vitapex | 5 | 2011 |
| Rhein'83 Srl | Italy | Maker | PIVOT FLEX PIVOT BLOCK; OT REVERSE 3 · 036PTN10 TITANIUM PIVOT NORMO h10 #5 · 036PTN9 TITANIUM PIVOT NORMO h9 #5 · 333PEK7 SET PIVOT + CAP OT EQUATOR h7 · +3 | 4 | 2018 |
| Bioloren S.R.L. | Italy | Maker | post | 3 | 2018 |
| Integra LifeSciences Corporation | United States | Maker | Inject-R-Fill · Integra Miltex · Miltex · Precise · +2 | 2 | 2014 |
| Cendres+Metaux SA | Switzerland | Maker | — | 2 | 2020 |
| Dental Technologies, Inc. | United States | Maker | Alpha-Cal | 2 | 2013 |
| Temrex Corp. | United States | Maker | DOC'S BEST RED / DOC'S BEST WHITE CANAL SEALER | 2 | 2012 |
| B&L Biotech Co., Ltd. | South Korea | Maker | B&L GP Gauge & Cutter- GGAC · B&L Gutta percha · Z.Post · Well-Paste | 1 | 2006 |
| Directa AB | Sweden | Maker | SendoCem MTA · SendoSeal MTA · ANCHORAGE POST · BURN OUT POST · +1 | 1 | 2015 |
| COLTENE Holding AG | Switzerland | Maker | HyFlex Guttapercha Points · Hygenic Gutta Percha Points · MicroMega Guttapercha Points · ROEKO GuttaFlow · +7 | 1 | 2003 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET BioRepair · KOMET BioSeal · KometSeal · KOMET GUTTAPERCHA · +2 | 1 | 2007 |
| Abrasive Technology, Inc. | United States | Maker | CARBOPOST · SNOWLIGHT · SNOWPOST | 1 | 1990 |
| BioMTA | South Korea | Maker | OrthoMTA(Mineral Trioxide Aggregate) · RetroMTA-OrthoMTA II · Smart MTA | 1 | 2014 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | Gutta Percha Points · Absorbent Paper Points | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Gutta Percha Points · dental marking pen · dental paper · root canal therapy-absorbent paper points · +1 | — | — |
| D.S.P. Industrial EIRELI EPP | Brazil | Maker | FORCEPOST DUAL CONE KIT · FORCEPOST DUAL CONE LARGE KIT · FORCEPOST REFILL 0.5 DC · FORCEPOST REFILL 0.5 DCL · +14 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Gutta Percha Cutter · Gutta Percha Points · Absorbent Paper Points · Dental Screw Post, Fibre Post, Glass Fibre post, Glass Fibre post Kit, Screw post, Orthodontic Microimplant | — | — |
| HSG-S Corp | United States | Maker | EdgeBioCeramic RetroFill and Perforation Repair · EdgeBioCeramic Sealer · EdgeBioCeramic ThermalFlow Sealer · EdgeUtopia Bioceramic Sealer · +10 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Absorbent Paper Point | — | — |
| US Endodontics, LLC | United States | Maker | AllFill · Burkhart Hybrid Gutta Carrier · Burkhart Thermal Obturator · Channels Obturator · +30 | — | — |
| B.J.M. Laboratories Ltd | Israel | Maker | BJM Root Canal Sealer · Obturys | — | — |
| Polydentia S.A. | Switzerland | Maker | Polydentia GF Posts | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Gutta Percha Point · Endo Drill · Endo File · Endo Reamer · +1 | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Gutta Percha Points | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Gutta-percha · Point, paper, endodontic | — | — |
| Dentatus AB | Sweden | Maker | Aztec · Classic · Luscent · Luscent-R · +3 | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | gutta-percha · point, paper, endodontic | — | — |
| Beyes Dental Inc | Canada | Maker | Curvea Gutta Percha; Curvea ONE Gutta Percha; Curvea CM Preserve Gutta Percha · Curvea Paper Points; Curvea ONE Paper Points; Curvea CM Preserve Paper Points | — | — |
| NTI Kahla GmbH Rotary Dental Instruments | Germany | Maker | Achromat fiber post · NTI | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | POINT, PAPER, ENDODONTIC · POST, ROOT CANAL | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | Gutta Percha Point · Absorbent Paper Point | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | Gutta percha points · Paper points · Fiber post - #20 · Fiber post - #25 · +2 | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | GUTTA-PERCHA · POINT, PAPER, ENDODONTIC | — | — |
| Digital Age Dental Laboratories, Ltd. | United States | Maker | Post and Core | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Gutta percha points · Absorbent paper points · Fiber Post | — | — |
| Innovative Material And Devices, Inc. | China | Maker | Gutta Percha | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VDEYA, Gutta Percha 2%&4%&6%, Model #15, #20, #25, #30, #35, #40, #45, #50, #55, #60, #70, #80, #15-#40, #45-#80 · VDEYA, Gutta Percha 2%&4%&6%, Model F1, F2, F3, F4, F5, F1-F3 · VDEYA, Paper Point 2%&4%&6%, Model #15, #20, #25, #30, #35, #40, #45, #50, #55, #60, #70, #80, #15-#40, #45-#80 · VDEYA, Paper Point 2%&4%&6%, Model F1, F2, F3, F4, F5, F1-F3 | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | GUTTA-PERCHA POINT,ABSORBENT PAPER POINTS · ENDODONTIC FILE | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | GUTTA PERCHA BAR · Fiber Post | — | — |
| Produits Dentaires SA | Switzerland | Maker | OdneFill · PD MTA White · Gutta-Percha Points · Absorbent Paper Points · +1 | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | GUTTA-PERCHA | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Gutta Percha Point · Absorbent Paper Points · Dental Root Canal Post; Screw Post / Quartz Fiber Post | — | — |
| Aadi Med Private Limited | India | Maker | Calahyd-RC (1.5g x 2 syr) · Calcium Hydroxide powder (15g, 30g, 100g) · Calx-O (1.5gm x 2 syr.) · Ceraseal-B (1g + 5ml) · +4 | — | — |
| Svenska Dentorama AB | Sweden | Maker | DENTORAMA CROSS KEY · DENTORAMA G-P SCREW POSTS · DENTORAMA HOLLOW KEY · DENTORAMA TIT. DENTINE PINS · +1 | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Accessory Gutta Percha points · Gutta Percha points · Absorbent Paper Points · Accessory Absorbent Paper Points | — | — |
| Viarden Lab LLC | United States | Maker | VIARDEN LAB GUTTAPERCHA POINTS, VIARDEN LAB PELLETS · PAPER POINT VIARDEN LAB · ENDODONTIC CEMENT VIARDEN LAB, MTA, CPE-R | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Gutta Percha Points · Absorbent Paper Points | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Gutta Percha Points, Injectable Root Canal Sealer · Absorbent Paper Points | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Gutta-percha · Point, Paper, Endodontic | — | — |
| Orikam Healthcare India Private Limited | India | Maker | Neoendo, Neoendo Gutta Percha Points, Gutta Percha Points · Neoendo, Neoendo Absorbent Paper Points, Absorbent Paper Points | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | GUTTA-PERCHA · POINT, PAPER, ENDODONTIC | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Absorbent Paper Points, Gutta Percha Points | — | — |
| Chengdu Sani Medical Equipment CO.,LTD. | China | Maker | Gutta Percha Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M, Gutta Percha Bar · Absorbent Paper Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M | — | — |
| Dongguan Integrity Medical Instrument Co.,Ltd. | China | Maker | Gutta Percha Point, Model: for Protaper with LengthMark · Gutta Percha Point, Model: Taper02, 04/06, for Protaper,Taper 02 with LengthMark,Taper 04/0/06 with LengthMark · Absorbent Paper Points, Model: Taper 02, Taper 04/0/06, for Protaper, Taper 02 with LengthMark · Absorbent Paper Points, Model:Taper 04/06 with LengthMark, for Protaper with LengthMark | — | — |
| J C India | India | Maker | Rainbow LC CAL · Rainbow LC GIC | — | — |
| United Dental Changzhou | China | Maker | Gutta percha points · Paper points | — | — |
| Creative Endodontic Technology LLC | United States | Maker | CET Gutta Percha Points · CET Absorbent Paper Points | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| E Hahnenkratt GmbH | Germany | Maker | HAHNENKRATT-JACKET-CROWN-POST · HAHNENKRATT-ROOT-PINS | — | — |
| Shandong Richsource Biological Technology Co.,Ltd | China | Maker | Dental Guard | — | — |
| Sure Dent Corporation | South Korea | Maker | Sure-Paste · Sure-Seal Root · GUTTA-PERCHA POINTS · ABSORBENT PAPER POINT | — | — |
| Unitron Group BV | Netherlands | Maker | GT Obturator Obturator Oven · GT Series X Obturator Oven · Guttamaster Obturator Oven · Profile Vortex Obturator Oven · +3 | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Gutta Percha | — | — |
| Harald Nordin S.A. | Switzerland | Maker | MECODONT PARALLEL SIDED POSTS · NORDIN CARBONITE CARBON FIBRE · NORDIN GLASSIX GLASS FIBRE · NORDIN GLASSIX PLUS GLASS FIBRE · +2 | — | — |
| Verdent Ltd. | Poland | Maker | Verdent Gutta Percha points | — | — |
| Cynosure LLC | United States | Maker | POST KIT | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | Gutta Purcha Points · Absorbent Paper Points | — | — |
| Jining Orodeka Medical Equipment Co Ltd | China | Maker | gutta percha points · paper point | — | — |
| TianJin Jieyaxin Medical Plastic Equipment Co., Ltd. | China | Maker | Gutta Percha Points, Gutta Percha Obturator · Absorbent Paper Points | — | — |
| CMS Dental A/S | Denmark | Maker | — | — | — |
| Shanwei Perfect Medical Instruments Co.,Ltd. | China | Maker | Gutta Percha Points | — | — |
| Aceonedent Korea lnd. Co. | South Korea | Maker | ACEONE-ENDO | — | — |
| Shanghai Xingyu Medical Equipment Co.,Ltd | China | Maker | Gutta Percha Points · Absorbent Paper Points | — | — |
| Tianjin Gapadent Co Ltd | China | Maker | GAPA | — | — |
| Cenova AB | Sweden | Maker | Sterile Surtex | — | — |
| iLumi Sciences inc | United States | Maker | Dental Fiber Post (U-Post, X-Post, E-Post) | — | — |
| Inno Dental Co Ltd | South Korea | Maker | Q.P Fiber Post Plus Refill · Q.P. Fiber Post Plus | — | — |
| Meta Biomed Vina One member Limited Liability Company | Vietnam | Maker | GUTTA-PERCHA · Endodontic Point Paper | — | — |
| Tianjin DiaDent Co., Ltd | China | Maker | GUTTA PERCHA POINTS · STERLI PAPER POINTS | — | — |
| Bazhou City Xin an Town Hexin Medical Material Factory | China | Maker | Absorbent Paper Points | — | — |
| Bio Composants Medicaux (BCM) | France | Maker | — | — | — |
| High Point Precision Products | United States | Maker | Root Canal Post | — | — |
| Jiangsu Yida Medical Equipment Co., Ltd | China | Maker | Gutta Percha Points | — | — |
| Hipp Medical AG | Germany | Maker | — | — | — |
| Pearl Dent Co Ltd | Vietnam | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Johnson Promident Posts · Obtura gutta percha | 23 | 2025 |
| Den-Mat Holdings, LLC | United States | Manufacturer | Core Post | 8 | 2026 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL GUTTA · DENTAL POINT PAPER | 5 | 2022 |
| J. Morita USA, Inc. | United States | Foreign exporter | CF Carbon Fiber Post · GF Glass Fiber Post | 42 | 2022 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | ApexSil RC · ApexSil Silver · ReMTA One · ZOER RC Automix | 2 | 2025 |
| Denjoy Dental Co., Ltd. | China | Contract manufacturer | JAS Gutta-Percha Pellets | 1 | 2025 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | Luminex · Parmax | 4 | 2004 |
| Hager Worldwide, Inc. | United States | Manufacturer | Mirafit · Mirapost | 2 | 2005 |
| Reliance Dental Mfg., LLC | United States | Manufacturer | Duralay Plastic Pins | 2 | 1987 |
| Synca Marketing | Canada | Foreign exporter | Biolight Advanced Fiber Post · Biolight Drill Free · Biolight Dual kit · Biolight Dual reamer #0.5 · +16 | 1 | 2010 |
| Sherpa | South Korea | Manufacturer | Gutta Percha | 1 | 2011 |
| DMG America, L.L.C. | United States | Contract manufacturer | Post, Root Canal - SPIRAPOST PFS · Spirapost PFS Introductory Package · Spirapost PFS Parallel Refill Package (10 Parallel Posts, 1 #5 Gates Glidden) · Spirapost-Parallel Posts · +1 | 1 | 2013 |
| Engineered Endodontics | United States | Repacker / relabeler | Filpost | 1 | 2019 |
| SS White Burs LLC | United States | Manufacturer | Gutta-Percha - SSW Gutta Percha, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE · Point, Paper, Endodontic - SSW Paper Point, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE · SS White Bioceramic Root Canal Sealer | 1 | 2008 |
| Sotera Health LLC | United States | Contract manufacturer | ABSORBENT S P P MAILLEFER W180 15 · ABSORBENT S P P MAILLEFER W180 15-40 · ABSORBENT S P P MAILLEFER W180 20 · ABSORBENT S P P MAILLEFER W180 25 · +66 | — | — |
| Sweden & Martina INC | United States | Lister | GUTTA-PERCHA POINTS | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Gutta Percha Points, #25, Taper Size 04, Color Coded · Valdent USA Gutta Percha Points, #45, Taper Size 04, Color Coded · Valdent USA Gutta Percha Points, Assorted #15-40, Taper Size 02, Color Coded · Valdent USA Gutta Percha Points, Assorted #15-40, Taper Size 04, Color Coded · +38 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental gutta percha point · GUTTA CUTTER · gutta percha point · Absorbent Paper Points · +4 | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | Adseal · AH PLUS ROOT CANAL SEALER · Apexit Root Canal Sealer · METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING · +5 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Toscana · orthom | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | AH Plus · dental cement · Gutta · Points · +1 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Gutta Percha Obturator · JMU Absorbent Paper Points | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | BIO-C SEALER ION+ · Bioactive Endosealer · Calcium Hydroxide · Patterson MTA Cement · +3 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | AH Plus · dental cement · dental resin · Gutta percha · +2 | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | AH Plus / 26 · Pulp Canal / EWT · Sealapex · Tubliseal / EWT | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | HyFlex Paper Points · Hygenic(HYG) Paper Points (PP), HYG Absorbent PP, HygenicSpectra Points Absorbent PP, HYG Ster-I-Cell PP, MicroMega Pape · ROEKO Paper Points | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DIA-PROSEAL · DIA-ROOT BIO MTA · DIA-ROOT BIO Sealer · DiaPaste · +4 | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Gutta · Points · Endo Drill; Endo File; Endo Reamer; Fiber Post | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Gutta-Percha ApicalShaper · Gutta-Percha BlueShaper · Gutta-Percha Excalibur · Gutta-Percha NanoShaper · +10 | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Repacker / relabeler | RSI Gutta Percha · RSI Paper Point | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill Gutta Percha Points | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Starryshine | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | AdSeal Root Canal Sealer · Metapaste Calcium Hydroxide With Barium · Metapex Calcium Hydroxide With Lodoform · SimpliSeal · +2 | — | — |
| Bina Limited | Belize | Foreign exporter | root canal filling · TIPS IRRIGATION MTA · GUTTA-PERCHA · paper points · +1 | — | — |
| Dental Brands for Less | Canada | Foreign exporter | DIADENT | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Root Canal Sealer | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | — | — | — |
| Novocol Pharmaceutical of Canada, Inc. | Canada | Foreign exporter | Biodentine | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Greenpia Technology Inc. | South Korea | Contract sterilizer | Absorbent Paper Points | — | — |
| CBR Enterprise Limited | Hong Kong SAR China | Foreign exporter | POST, ROOT CANAL | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | EndoCeramic Root Repair Material | — | — |
| Research and Development Center for Radiation Technology (VI | Vietnam | Contract sterilizer | Endodontic Point Paper | — | — |
| Shanghai Jpy Ion-Tech Co., Ltd. | China | Contract sterilizer | PINNACLE GRIPTION | — | — |
| B And B Investment Company Limited | Vietnam | Foreign exporter | — | — | — |
| Digital Arches Inc. | United States | Repacker / relabeler | — | — | — |
| 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 | — | — | — |
| Xlent Global Inc | United States | Repacker / relabeler | — | — | — |
| Zircon Plus Limited | Israel | Foreign 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 root canal filling materials are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Gutta-PerchaEKM | 1 | 872.3850 | 64 | 23 |
| Root Canal PostELR | 1 | 872.3810 | 54 | 35 |
| Endodontic Paper PointEKN | 1 | 872.3830 | 49 | 7 |
| Root Canal Filling ResinKIF | 2 | 872.3820 | 39 | 148 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Oct 2026 | K262478 | BCS Bioceramic Sealer | BCS Device Pte., Ltd. | KIF Root Canal Filling Resin |
| 11 Sep 2026 | K262050 | Vioseal X | Spident Co., Ltd. | KIF Root Canal Filling Resin |
| 4 Sep 2026 | K253909 | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. | KIF Root Canal Filling Resin |
| 25 Aug 2026 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | KIF Root Canal Filling Resin |
| 29 Jun 2026 | K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | KIF Root Canal Filling Resin |
| 12 Jan 2026 | K253167 | Any-Paste | Mediclus Co., Ltd | KIF Root Canal Filling Resin |
| 7 Jan 2026 | K252890 | ZenSeal Pro | Sybron Dental Specialties | KIF Root Canal Filling Resin |
| 25 Sep 2025 | K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd | KIF Root Canal Filling Resin |
| 19 Sep 2025 | K252285 | Well-Root PT | Vericom Co., Ltd. | KIF Root Canal Filling Resin |
| 22 Aug 2025 | K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd | KIF Root Canal Filling Resin |
| 3 Jul 2025 | K251390 | MTA vpt | Voco GmbH | KIF Root Canal Filling Resin |
| 11 Jun 2025 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | KIF Root Canal Filling Resin |
| 14 Mar 2025 | K243353 | One-Fil Putty | Mediclus Co., Ltd | KIF Root Canal Filling Resin |
| 13 Feb 2025 | K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | KIF Root Canal Filling Resin |
| 12 Dec 2024 | K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | KIF Root Canal Filling Resin |
| 7 Nov 2024 | K242702 | VioSeal | Spident Co., Ltd. | KIF Root Canal Filling Resin |
| 3 Oct 2024 | K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | KIF Root Canal Filling Resin |
| 28 Aug 2024 | K241457 | Vista BC Putty | Inter-Med, Inc. | KIF Root Canal Filling Resin |
| 30 Jul 2024 | K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | KIF Root Canal Filling Resin |
| 28 May 2024 | K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | Enpuno Biotechnology Co., Ltd | KIF Root Canal Filling Resin |
| 10 May 2024 | K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., LTD. | KIF Root Canal Filling Resin |
| 26 Jan 2024 | K232182 | One-Fil | Mediclus Co., Ltd | KIF Root Canal Filling Resin |
| 29 Sep 2023 | K232299 | CeraPutty | Meta Biomed Co, Ltd | KIF Root Canal Filling Resin |
| 28 Jul 2023 | K231480 | Bright MTA Sealer Plus | GENOSS Co., Ltd. | KIF Root Canal Filling Resin |
| 10 Jul 2023 | K231387 | Endofill | Lumendo AG | KIF Root Canal Filling Resin |
| 31 May 2023 | K231259 | iRoot SP Plus | Innovative Bioceramix, Inc. | KIF Root Canal Filling Resin |
| 13 Apr 2023 | K230010 | ADSEAL Plus | Meta Biomed Co, Ltd | KIF Root Canal Filling Resin |
| 24 Mar 2023 | K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. | KIF Root Canal Filling Resin |
| 14 Feb 2023 | K213757 | Endocem MTA Premixed Regular | Maruchi | KIF Root Canal Filling Resin |
| 22 Nov 2022 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | Innovative Bioceramix, Inc. | KIF Root Canal Filling Resin |
| 21 Nov 2022 | K221811 | Vista BC Sealer | Inter-Med, Inc. | KIF Root Canal Filling Resin |
| 23 May 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | KIF Root Canal Filling Resin |
| 8 Dec 2021 | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., LTD. | KIF Root Canal Filling Resin |
| 13 Oct 2021 | K211905 | UltraCal XS | Ultradent Products, Inc. | KIF Root Canal Filling Resin |
| 16 Sep 2021 | K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Septodont | KIF Root Canal Filling Resin |
| 27 Aug 2021 | K211995 | Sonendo Filling Material 5C | Sonendo, Inc. | KIF Root Canal Filling Resin |
| 13 Aug 2021 | K212229 | White Endoseal MTA | Maruchi | KIF Root Canal Filling Resin |
| 10 Aug 2021 | K211799 | Biodentine XP 500, Biodentine XP 200 | Septodont | KIF Root Canal Filling Resin |
| 30 Jun 2021 | K210904 | Metapaste Plus | Meta Biomed Co, Ltd | KIF Root Canal Filling Resin |
| 14 Apr 2021 | K202617 | Metapex Plus | Meta Biomed Co, Ltd | KIF Root Canal Filling Resin |