Prosthetic devices · 21 CFR 872 Subpart D
Gutta-Percha
FDA device type “Gutta-Percha”.
- Companies listing it
- 9964 makers
- Brands and models
- 219
- 510(k) clearances
- 230 in five years
- FDA name
- Gutta-Percha
510(k) clearances per year, 1976–2026
Companies that list EKM
99 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | Gutta Percha · GUTTA PERCHA POINTS | 22 | 2026 |
| DiaDent Group International | South Korea | Maker | GUTTA PERCHA OBTURATOR · GUTTA PERCHA POINTS | 24 | 2026 |
| Sybron Dental Specialties | United States | Maker | Autofit Backfill Gutta Percha · Autofit Gutta Percha · Elements Gutta Percha Cartridge · Gutta Percha · +14 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Endo-Eze Genius Gutta Percha · EndoREZ Points | 95 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | Gutta Percha Bar Plus · GUTTA PERCHA CARTRIDGE · Gutta Percha Points and Bars · Smart Fit GP | 24 | 2024 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | Gutta Percha Points and Bar | 3 | 2026 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Gutta Percha, Gutta Cutter | 4 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Gutta Percha Cutter, Gutta Percha Obturator | 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 | 1 | 2023 |
| 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 |
| SWEDEN & MARTINA S.p.A. | Italy | Maker | STARTER PACK | 6 | 2019 |
| Integra LifeSciences Corporation | United States | Maker | Inject-R-Fill · Integra Miltex · Miltex · Precise · +1 | 2 | 2014 |
| B&L Biotech Co., Ltd. | South Korea | Maker | B&L GP Gauge & Cutter- GGAC · B&L Gutta percha | 1 | 2006 |
| COLTENE Holding AG | Switzerland | Maker | HyFlex Guttapercha Points · Hygenic Gutta Percha Points · MicroMega Guttapercha Points · ROEKO GuttaFlow · +2 | 1 | 2003 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | Gutta Percha Points | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Gutta Percha Points | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Gutta Percha Cutter · Gutta Percha Points | — | — |
| HSG-S Corp | United States | Maker | EdgeAccessory · EdgeCore for EdgeEndo® · EdgeCore for EdgeOne · EdgeCore for EdgeTaper · +5 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| US Endodontics, LLC | United States | Maker | AllFill · Burkhart Hybrid Gutta Carrier · Burkhart Thermal Obturator · Channels Obturator · +30 | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Gutta Percha Point | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Gutta Percha Points | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Gutta-percha · Point, paper, endodontic | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | gutta-percha | — | — |
| Beyes Dental Inc | Canada | Maker | Curvea Gutta Percha; Curvea ONE Gutta Percha; Curvea CM Preserve Gutta Percha | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | Gutta Percha Point | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | GUTTA-PERCHA | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Gutta percha points | — | — |
| 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 | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | GUTTA-PERCHA POINT,ABSORBENT PAPER POINTS | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | GUTTA-PERCHA | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Gutta Percha Point | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Accessory Gutta Percha points · Gutta Percha points | — | — |
| Viarden Lab LLC | United States | Maker | VIARDEN LAB GUTTAPERCHA POINTS, VIARDEN LAB PELLETS | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Gutta Percha Points | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Gutta Percha Points, Injectable Root Canal Sealer | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Gutta-percha | — | — |
| Orikam Healthcare India Private Limited | India | Maker | Neoendo, Neoendo Gutta Percha Points, Gutta Percha Points | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | GUTTA-PERCHA | — | — |
| 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 | — | — |
| 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 | — | — |
| United Dental Changzhou | China | Maker | Gutta percha points | — | — |
| Creative Endodontic Technology LLC | United States | Maker | CET Gutta Percha Points | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Shandong Richsource Biological Technology Co.,Ltd | China | Maker | Dental Guard | — | — |
| Sure Dent Corporation | South Korea | Maker | GUTTA-PERCHA POINTS | — | — |
| 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 | — | — |
| Verdent Ltd. | Poland | Maker | Verdent Gutta Percha points | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | Gutta Purcha Points | — | — |
| Jining Orodeka Medical Equipment Co Ltd | China | Maker | gutta percha points | — | — |
| TianJin Jieyaxin Medical Plastic Equipment Co., Ltd. | China | Maker | Gutta Percha Points, Gutta Percha Obturator | — | — |
| 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 | — | — |
| Tianjin Gapadent Co Ltd | China | Maker | GAPA | — | — |
| Meta Biomed Vina One member Limited Liability Company | Vietnam | Maker | GUTTA-PERCHA | — | — |
| Tianjin DiaDent Co., Ltd | China | Maker | GUTTA PERCHA POINTS | — | — |
| Jiangsu Yida Medical Equipment Co., Ltd | China | Maker | Gutta Percha Points | — | — |
| Pearl Dent Co Ltd | Vietnam | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Obtura gutta percha | 23 | 2025 |
| Pac-Dent Inc. | United States | Contract manufacturer | JS Dental | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL GUTTA | 5 | 2022 |
| J. Morita USA, Inc. | United States | Foreign exporter | — | 42 | 2022 |
| Essential Dental Systems, Inc. | United States | Repacker / relabeler | Safesider HF Gutta Percha Points · SafeSiders Gutta Percha Points | 15 | 2023 |
| NuSmile, Ltd. | United States | Manufacturer | ApicalShaper Gutta-Percha · BlueShaper Gutta-Percha · Excalibur Gutta-Percha · Excalibur Mini Gutta-Percha · +6 | 2 | 2026 |
| Denjoy Dental Co., Ltd. | China | Contract manufacturer | JAS Gutta-Percha Pellets | 1 | 2025 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Contract manufacturer | KOMET GUTTAPERCHA | 1 | 2007 |
| Sherpa | South Korea | Manufacturer | Gutta Percha | 1 | 2011 |
| SS White Burs LLC | United States | Manufacturer | Gutta-Percha - SSW Gutta Percha, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE | 1 | 2008 |
| 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 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental gutta percha point · GUTTA CUTTER · gutta percha point | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Toscana | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Gutta | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Gutta Percha Obturator | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Gutta Percha, Sterile and Non Sterile | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Gutta percha | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | GUTTA PERCHA OBTURATOR · GUTTA PERCHA POINTS | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Gutta | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Gutta-Percha ApicalShaper · Gutta-Percha BlueShaper · Gutta-Percha Excalibur · Gutta-Percha NanoShaper · +3 | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Foreign exporter | GUTTA PERCHA BAR | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Repacker / relabeler | RSI Gutta Percha | — | — |
| Produits Dentaires SA | Switzerland | Contract manufacturer | Gutta-Percha Points | — | — |
| 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 | Gutta Percha Point | — | — |
| Bina Limited | Belize | Foreign exporter | GUTTA-PERCHA | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Xlent Global Inc | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 Feb 2008 | K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg Co., LLC |
| 16 Feb 2007 | K070246 | DOWN PAK | Endo Twinn B.V. |
| 26 Jun 2006 | K051573 | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | Dr. Howard Martin, P.A. |
| 11 Jan 2005 | K042870 | ENDO TWINN | Endo Twinn B.V. |
| 26 Mar 2003 | K023819 | FIBERFILL SGP | Pentron Clinical Technologies |
| 21 Jul 1997 | K971641 | ANTIBACTERIAL GUTTA PERCHA | Dr. Howard Martin, P.A. |
| 21 Mar 1997 | K970134 | THERMAPREP PLUS OVEN | Dentsply Sirona, Inc. |
| 27 May 1993 | K931742 | INJECT-R FILL | Union Broach, Div. Moyco Industries, Inc. |
| 5 Mar 1993 | K924825 | MICRODOSE RC-EZ | Unicep |
| 21 Jan 1992 | K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology |
| 29 Mar 1991 | K910224 | THERMAPREP | Dentsply Sirona, Inc. |
| 13 Nov 1990 | K900986 | THERMAFIL ENDODONTIC OBTURATOR | Dentsply Sirona, Inc. |
| 14 Feb 1990 | K896663 | ENDO-PREP | Pulpdent Corporation |
| 7 Apr 1988 | K881139 | THERMAFIL ENDODONTIC OBTURATOR | Dentsply Sirona, Inc. |
| 30 Oct 1986 | K863638 | GUTTA PERCHA POINTS | Endodent, Inc. |
| 30 Oct 1986 | K863411 | GUTTA PERCHA | Endodent, Inc. |
| 22 Jul 1986 | K862129 | SET CANAL SEALER PASTE | Endo Technic Corp. |
| 16 Apr 1985 | K850863 | ULTRAFIL-LT (GUTTA PERCHA) | The Hygenic Company, LLC |
| 26 Sep 1983 | K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. |
| 1 Mar 1983 | K830115 | PAPER POINTS | North Pacific Dental, Inc. |
| 1 Mar 1983 | K830114 | GUTTA PERCHA POINTS | North Pacific Dental, Inc. |
| 18 Jan 1983 | K823486 | TOUCH-N-HEAT MODEL 5001 | Analytic Technology |
| 9 Apr 1982 | K820639 | OBTURATION SYSTEM KIT | U.S. Shizai Corp. |
Official records: FDA product classification for EKM · 21 CFR 872.3850.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026