Prosthetic devices · 21 CFR 872 Subpart D
Endodontic Paper Point
FDA device type “Point, Paper, Endodontic”.
- Companies listing it
- 8249 makers
- Brands and models
- 186
- 510(k) clearances
- 70 in five years
- FDA name
- Point, Paper, Endodontic
510(k) clearances per year, 1976–2026
Companies that list EKN
82 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Caulk Post & Core Kit · Paper Points | 148 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | Absorbent Paper Accessory Points · PAPAER POINTS · Paper Point | 22 | 2026 |
| DiaDent Group International | South Korea | Maker | ABSORBENT PAPER POINTS(STERII.E PAPER POINTS) | 24 | 2026 |
| Sybron Dental Specialties | United States | Maker | Autofit Paper Points · K3/K3XF Paper Points · PAPER POINTS · TF Adaptive Paper Points · +2 | 203 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | Absorbent Paper Points | 24 | 2024 |
| Premier Dental Products Company | United States | Maker | Premier Absorbent Points | 28 | 2026 |
| Pac-Dent Inc. | United States | Maker | JS Dental | 5 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Absorbent Paper Points | 1 | 2025 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Fliex · NIC · ROOT.X · SUPERFILE | 1 | 2025 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | Absorbent Paper Points | 1 | 2023 |
| COLTENE Holding AG | Switzerland | Maker | HyFlex Paper Points · Hygenic(HYG) Paper Points (PP), HYG Absorbent PP, Hygenic Spectra Points Absorbent PP, HYG Steri-I-Cell PP · MicroMega Paper Points · ROEKO Paper Points | 1 | 2003 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | Absorbent Paper Points | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | dental marking pen · dental paper · root canal therapy-absorbent paper points | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Absorbent Paper Points | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Absorbent Paper Point | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | point, paper, endodontic | — | — |
| Beyes Dental Inc | Canada | Maker | Curvea Paper Points; Curvea ONE Paper Points; Curvea CM Preserve Paper Points | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | POINT, PAPER, ENDODONTIC | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | Absorbent Paper Point | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | Gutta percha points · Paper points | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | POINT, PAPER, ENDODONTIC | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Absorbent paper points | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | 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 | ENDODONTIC FILE | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Absorbent Paper Points | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Absorbent Paper Points · Accessory Absorbent Paper Points | — | — |
| Viarden Lab LLC | United States | Maker | PAPER POINT VIARDEN LAB | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Absorbent Paper Points | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Absorbent Paper Points | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Point, Paper, Endodontic | — | — |
| Orikam Healthcare India Private Limited | India | Maker | Neoendo, Neoendo Absorbent Paper Points, Absorbent Paper Points | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | 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 | Absorbent Paper Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M | — | — |
| Dongguan Integrity Medical Instrument Co.,Ltd. | China | Maker | 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 | — | — |
| United Dental Changzhou | China | Maker | Paper points | — | — |
| Creative Endodontic Technology LLC | United States | Maker | CET Absorbent Paper Points | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Sure Dent Corporation | South Korea | Maker | ABSORBENT PAPER POINT | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | Absorbent Paper Points | — | — |
| Jining Orodeka Medical Equipment Co Ltd | China | Maker | paper point | — | — |
| TianJin Jieyaxin Medical Plastic Equipment Co., Ltd. | China | Maker | Absorbent Paper Points | — | — |
| Aceonedent Korea lnd. Co. | South Korea | Maker | ACEONE-ENDO | — | — |
| Shanghai Xingyu Medical Equipment Co.,Ltd | China | Maker | Absorbent Paper Points | — | — |
| Tianjin Gapadent Co Ltd | China | Maker | GAPA | — | — |
| Meta Biomed Vina One member Limited Liability Company | Vietnam | Maker | Endodontic Point Paper | — | — |
| Tianjin DiaDent Co., Ltd | China | Maker | STERLI PAPER POINTS | — | — |
| Bazhou City Xin an Town Hexin Medical Material Factory | China | Maker | Absorbent Paper Points | — | — |
| Pearl Dent Co Ltd | Vietnam | Maker | — | — | — |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL POINT PAPER | 5 | 2022 |
| J. Morita USA, Inc. | United States | Foreign exporter | — | 42 | 2022 |
| NuSmile, Ltd. | United States | Manufacturer | ApicalShaper Paper Point · BlueShaper Paper Point · Excalibur Mini Paper Point · Excalibur Paper Point · +6 | 2 | 2026 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Contract manufacturer | KOMET PAPER POINTS | 1 | 2007 |
| SS White Burs LLC | United States | Manufacturer | Point, Paper, Endodontic - SSW Paper Point, EXACTFLOW, EXACTTAPER, EXACTTAPERH, EXACTGUIDE | 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 · +65 | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Absorbent Paper Points, #15-40, Taper Size 04 · Valdent USA Absorbent Paper Points, #15, Taper Size 02 · Valdent USA Absorbent Paper Points, #15, Taper Size 06 · Valdent USA Absorbent Paper Points, #25, Taper Size 04, Red · +5 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | Absorbent Paper Points · paper point | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Toscana | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Points | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Absorbent Paper Points | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Paper Points, Bulk and Sterile | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | paper point | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | — | — | — |
| 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 | ABSORBENT PAPER POINTS(Sterile Paper Points) | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Points | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Paper Points ApicalShaper · Paper Points BlueShaper · Paper Points Excalibur · Paper Points NanoShaper · +3 | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Foreign exporter | — | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Repacker / relabeler | RSI Paper Point | — | — |
| Produits Dentaires SA | Switzerland | Contract manufacturer | Absorbent Paper Points | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Starryshine | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | Paper Point | — | — |
| Bina Limited | Belize | Foreign exporter | paper points | — | — |
| Dental Brands for Less | Canada | Foreign exporter | DIADENT | — | — |
| Greenpia Technology Inc. | South Korea | Contract sterilizer | Absorbent Paper Points | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | — | — | — |
| Research and Development Center for Radiation Technology (VI | Vietnam | Contract sterilizer | Endodontic Point Paper | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 9 Jan 1985 | K843017 | ABSORBENT ENDODONTIC POINT | United Dental Mfg., Inc. |
| 14 Jun 1982 | K821625 | ENDODONTIC PAPERPOINTS | Roeko |
| 16 Nov 1981 | K812886 | ENDODONTIC PAPER POINTS | United Dental Mfg., Inc. |
| 29 Apr 1980 | K800827 | PREMIER ABSORBENT POINTS | Premier Dental Products Company |
| 10 Oct 1978 | K781605 | R&R ABSORBENT POINTS | Ransom & Randolph. LLC. |
| 13 Dec 1976 | K761203 | ABSORBENT POINTS | Johnson & Johnson Professionals, Inc. |
| 15 Nov 1976 | K760983 | ENDODONTIC INSTRUMENTS | Adp Intl., Inc. |
Official records: FDA product classification for EKN · 21 CFR 872.3830.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026