Surgical devices · 21 CFR 872 Subpart E
Dental Needle
FDA device type “Needle, Dental”.
- Companies listing it
- 13999 makers
- Brands and models
- 232
- 510(k) clearances
- 160 in five years
- FDA name
- Needle, Dental
510(k) clearances per year, 1976–2026
Companies that list DZM
139 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | — | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Jenker Needle Stick Protector · X-Tip Intraosseous Injection Sys | 148 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | NOP Dental Needles | 22 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | Dental Needle 27G x 21MM | 68 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Tips of Ultrasonic Endo Activate | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | MIxing Tips | 203 | 2026 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| Premium Plus (Dongguan) Limited | China | Maker | Applicator tips · Flowable composite and etching gel tips | 2 | 2025 |
| Beijing C-Root Dental Medical Devices Co., LTD. | China | Maker | Disposable tips | 2 | 2024 |
| Coltene/Whaledent AG | Switzerland | Maker | CanalPro Irrigating Tips | 45 | 2022 |
| Maruchi | South Korea | Maker | AH Plus® Bioceramic Sealer Endodontic Cannulas | 8 | 2023 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Disposable/Dental Irrigation Needle, Disposable/Dental Irrigation Syringe, | 4 | 2022 |
| Shinhung Company, Ltd. | South Korea | Maker | K-irrigator tips · SHINJECT | 2 | 2023 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | (dental)needle, Root Canal Irrigation Needle | 1 | 2025 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | Irrigation Needle | 1 | 2023 |
| Pulpdent Corporation | United States | Maker | Applicator tips · Pressure syringe needles | 107 | 2021 |
| Septodont | France | Maker | — | 17 | 2021 |
| Neodental Chemical Products Co., Ltd. | Japan | Maker | Neo Blue Tips · Neo Clear Tips | 5 | 2011 |
| B&L Biotech Co., Ltd. | South Korea | Maker | Beta · BMN2420 · BMN2423 · BMN2425 · +46 | 1 | 2006 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | SONIC IRRIGATOR TIP, IRRIGATION NEEDLE TIPS | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental needles · Dispensing Tip · Pre-Bent Needle Tip | — | — |
| Dental Studio | South Korea | Maker | NSI Buddy | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | (dental)needle, Root Canal Irrigation Needle | — | — |
| Practicon, Inc. | United States | Maker | Practicon 33G Dental Needle · PractiShield | — | — |
| Technimen Skillers | Pakistan | Maker | DENTAL NEEDLES · VARIOUS TYPES OF SURGICAL | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Needle | — | — |
| Endo Tech Instruments | Pakistan | Maker | Dental Needle Holders | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Dental Delivery Needle · Dental Needle · Irrigation Needle · Pre-bent Needle | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Air/water Syringe tip · Curved Utility Syringe · Dental headlight · Dental loupes/magnifier · +2 | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Dental Irrigation needle/tips · Disposable dental needles | — | — |
| Lacigrus International | Pakistan | Maker | NEEDLE, DENTAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | NEEDLE DENTAL | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | dental Irrigation needle/tips · Disposable Dental Needles | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | CanlPro Tips · NEEDLE, DENTAL | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | Probe C · Probe F · Probe S | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | Irrigation needle - 0.3MM · Irrigation needle - 0.4MM · Irrigation needle - 0.5MM · irrigation needle ruber dam | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Dental needle | — | — |
| BH Medical Products Co., Ltd | China | Maker | Needle sheath card · needle sheath prop | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Dispensing tip · Pre-bent needle tip | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | NEEDLE · NEEDLE, DENTAL | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | Irrigation Needle | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | NEEDLE, DENTAL | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Dental needles · Irrigation needle · Sealant cement | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Dental needle, Prevent tips | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Needle, Dental | — | — |
| Boen Healthcare Co Ltd | China | Maker | Dental Needle, Dental Anesthesia Needle | — | — |
| Huzhou Junda Industry Co., Ltd. | China | Maker | Buried needle · Dental Irrigation Needle · Dental needles · Disposable Hypodermic needle · +5 | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Dental Needle | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | dental needles /Irrigation Needle · sealant cement | — | — |
| G.S.T. Corporation Limited | India | Maker | Gold Cross · GSTC · Heuer | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | STAR JECT · STAR JECT ENDO | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Needle, Dental | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Dental Needle CHIRMED | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Dental anesthesia needle | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Needle, Dental | — | — |
| Win Wings Corp. | Pakistan | Maker | NEEDLE, DENTAL | — | — |
| medmix Deutschland GmbH | Germany | Maker | Painless Steel | — | — |
| Greens Surgicals Private Limited | India | Maker | GREENS | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Maker | Syringe tip | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Skill To Tech International | Pakistan | Maker | NEEDLE, DENTAL | — | — |
| Pierrel S.p.A. | Italy | Maker | Orabloc thirtyES · Orabloc thirtyS · Orabloc twenty5L · Orabloc twenty7L · +1 | — | — |
| Zhejiang Lidesen Medical Instrument Co., Ltd | China | Maker | Dental Needle | — | — |
| Jiangyin Nanquan Macromolecule Product Co Ltd | China | Maker | Dental anesthesia needle | — | — |
| Anji SPENQ Industrial Co., Ltd. | China | Maker | Dental Needle | — | — |
| Foshan Gladent Medical Instrument Co.,Ltd. | China | Maker | NEEDLE, DENTAL-Dental Burs | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | 9724068 | — | — |
| Shanghai Joy Crown Industry Co., Ltd | China | Maker | JOY155 | — | — |
| China Zhong Yan Chang ING International Co, LTD | China | Maker | Needle Dental | — | — |
| Fairfax MEDICAL PRODUCTS Ltd | United Kingdom | Maker | Stabident | — | — |
| Ningbo Caremed Medical Products Co Ltd | China | Maker | Medeco · Plastcare USA | — | — |
| Ningbo Greetmed Medical Instruments Co., Ltd. | China | Maker | dental needle | — | — |
| Berpu Medical Technology Co., Ltd. | China | Maker | Sterile Dental Needles for Single Use · Sterile Irrigation Needle for Single Use | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Exelint International Co | United States | Maker | Superject Sterile Disposable Dental Needles | — | — |
| Shandong Caremed Medical Products Co.,Ltd. | China | Maker | NEEDLE, DENTAL | — | — |
| Tochigi Seiko Co., Ltd. | Japan | Maker | Ninjection Dental Needle · STERIJECT | — | — |
| 3D Dental Designs and Development LLC | United States | Maker | — | — | — |
| Anhui Kangda Medical Products Co., Ltd. | China | Maker | BAIXIN DENTAL NEEDLE | — | — |
| Dental Products Lab | United States | Maker | NopoGuard | — | — |
| Jiangsu Zhongsheng Medical Technology Co..ltd | China | Maker | NEEDLE, DENTAL | — | — |
| Nipro Corporation | Japan | Maker | Dental Needle | — | — |
| SMENG co.,ltd. | South Korea | Maker | SM ENG CO.,LTD, | — | — |
| Sofic | France | Maker | Effitec | — | — |
| Sungshim Medicare Co.,Ltd. | South Korea | Maker | Sungshim Dental Needle | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Air Water Realize Inc. | Japan | Maker | — | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| CK Dental Ind Co Ltd | South Korea | Maker | — | — | — |
| Pearl Dent Co Ltd | Vietnam | Maker | — | — | — |
| Tecnofar S.p.A | Italy | Maker | — | — | — |
| United Plastics Group(Suzhou)Co.,Ltd | China | Maker | — | — | — |
| Wenzhou Aochang Misawa Medical Tech. Co., Ltd | China | Maker | — | — | — |
| Xlent Global Inc | United States | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Vericom Co., Ltd. | South Korea | Manufacturer | — | 20 | 2026 |
| Keystone Industries | United States | Contract manufacturer | Prehma Disposable Dental Needles | 2 | 2025 |
| J. Morita USA, Inc. | United States | Foreign exporter | MORITA DISPOSABLE DENTAL NEEDLE | 42 | 2022 |
| Dental Hi Tec | France | Foreign exporter | Effitec needles | 1 | 2025 |
| Dxm Co., Ltd. | South Korea | Contract manufacturer | DXM BENDABLE/PRE-BEND NEEDLE TIP · MISO | 6 | 2020 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| George Taub Products & Fusion Co., Inc. | United States | Manufacturer | Tips - Applicator - Luer | 2 | 1986 |
| Dfl Industria E Comercio SA | Brazil | Contract manufacturer | Dencojet · Unoject | 2 | 2013 |
| Sotera Health LLC | United States | Contract manufacturer | SimpleCAP · X-TIP | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Endodontic Irrigation Needle, 27ga, 3cc, Yellow | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental irrigation needle · DENTAL NEEDLE · dental needle tip with brush · DISPOSABLE DENTAL NEEDLE · +3 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental Needle · Needle Dental | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Dental Anesthetic Needle | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Disposable Plastic Hub Needles · Plastic Hub Dental Needles | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Dental Needle | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | Edge Irrigation Probe Tips · Edge Irritation Needle Tips · EdgeEndo | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Dental Needle | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| battech | United States | Repacker / relabeler | dental prebent tips | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Dispensing Tip · Pre-Bent Needle Tip | — | — |
| Beaming White LLC | United States | Manufacturer | Syringe Tip | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | DENTAL NEEDLE TIPS, BENT NEEDLE TIPS, IRRIGATION NEEDLE TIPS | — | — |
| Midwest Dental | United States | Repacker / relabeler | — | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | — | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Foreign exporter | Disposable Dental Needles | — | — |
| Novocol Pharmaceutical of Canada, Inc. | Canada | Foreign exporter | Benco · Darby · Evolution · Henry Schein · +6 | — | — |
| Shanghai Carelife International Trading Co. LTD | China | Foreign exporter | PLASDENT | — | — |
| Global-Tec Enterprises, Inc. | United States | Repacker / relabeler | Jiangyin | — | — |
| Hospital & Homecare Imp. & Exp. Co., Ltd | China | Foreign exporter | NEEDLE, DENTAL | — | — |
| HA2 Medizintechnik GmbH | Germany | Contract sterilizer | Transcodent Dental Needle | — | — |
| U&U Medical Technology Co., Ltd | Hong Kong SAR China | Foreign exporter | Dental Needle | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Dasol International Ltd. | South Korea | Contract sterilizer | Sani-Needle | — | — |
| Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. | China | Foreign exporter | — | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 Apr 1999 | K990511 | X-TIP INTRAOSSEOUS PERFORATOR | Schiff & Co. |
| 28 Apr 1992 | K920758 | JENKER NEEDLE STICK PROTECTOR | Dentsply Intl., Inc. |
| 9 Mar 1992 | K914562 | ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM | Aseptic Dental Technologies, Inc. |
| 7 Nov 1991 | K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Specialites Septodont |
| 13 Sep 1991 | K910475 | DENTAL NEEDLE PROTECTIVE SYSTEM | Health Technology Systems, Inc. |
| 3 Jun 1991 | K910446 | STABIDENT LOCAL ANESTHESIA SYSTEM | Fairfax Dental, Inc. |
| 22 Jan 1990 | K896219 | SAFE-T-CAP NEEDLE COVER | Ausmedics Pty , Ltd. |
| 13 Oct 1989 | K894373 | NIPRO DENTAL NEEDLE | Pharma-Plast USA, Inc. |
| 3 Apr 1987 | K870921 | DENTAL NEEDLE (CARTRIDGE TYPE) | Churchill Corp. |
| 10 Mar 1987 | K864970 | TERUMO DENTAL NEEDLES | Terumo Medical Corp. |
| 11 Apr 1986 | K861150 | EXEL DENTAL NEEDLE | Exel Intl. |
| 23 Sep 1985 | K851524 | SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE | Specialites Septodont |
| 30 Mar 1984 | K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Smith & Nephew, Mpl Division |
| 9 Apr 1982 | K820568 | MUSCLE DYSFUNCTION MONITOR | A Company, Inc. |
| 24 Nov 1980 | K802811 | MONOJECT ROOT CANAL FILLING MAT. NEEDLE | Sherwood Medical Co. |
| 13 Dec 1976 | K761206 | INTEROSSEOUS NEEDLE | Smith & Nephew, Mpl Division |
Official records: FDA product classification for DZM · 21 CFR 872.4730.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026