Surgical devices · 21 CFR 872 Subpart E
Irrigating Endodontic Periodontic Syringe
FDA device type “Syringe, Periodontic, Endodontic, Irrigating”.
- Companies listing it
- 13391 makers
- Brands and models
- 226
- 510(k) clearances
- 160 in five years
- FDA name
- Syringe, Periodontic, Endodontic, Irrigating
510(k) clearances per year, 1976–2026
Companies that list EIC
133 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 |
| Ultradent Products, Inc. | United States | Maker | Capillary Tips · Deliver-Eze Irrig. & Evac. Kit · Endo-Eze Irrig. Tips · Endo-Eze Tips · +11 | 95 | 2026 |
| Inter-Med, Inc. | United States | Maker | Appli-Vac · Colored Syringe · Dripless · Exacta-Flo · +11 | 7 | 2026 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Beijing C-Root Dental Medical Devices Co., LTD. | China | Maker | C-Root Sodium Hypochlorite Solution (3%, 5%, 5.25%) | 2 | 2024 |
| Coltene/Whaledent AG | Switzerland | Maker | CanalPro Color Syringes | 45 | 2022 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Endo Irrigation Tips, Disposable Endo Irrigation Tips | 4 | 2022 |
| Cavex Holland BV | Netherlands | Maker | Vibringe | 26 | 2015 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | BIO-C SEALER Tips · ENDO TIPS · MTA-FILLAPEX MIXING TIPS · Triple Tips | 11 | 2021 |
| Micron Corporation | Japan | Maker | — | 5 | 2018 |
| Dharma Research, Inc. | United States | Maker | ADS Chlorhexidine Irrigation Solution · ADS EDTA Irrigation Solution · ADS Enhanced Sodium Hypochlorite Solution · ADS Sodium Hypochlorite Solution · +8 | 1 | 2015 |
| Seilglobal CO., Ltd | South Korea | Maker | Composite Syringe · Dual Syringe · Flow Syringe | 1 | 2015 |
| ErgoDenta ApS | Denmark | Maker | Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread · Cylinder Cartridge Syringe, 1.8 ml, Chrome-plated, with Metric Thread, without aspiration · Cylinder Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread, with aspiration · Cylinder Cartridge Syringe, 2.2 ml, Chrome-plated, with Metric Thread, without aspiration · +7 | — | — |
| Zain's Medical Image | Pakistan | Maker | Aspirating Syringe · Aspirating Syringe 2 1/2 Rings · Aspirating Syringe Folding Type · Aspirating Syringe, Cook-Waite (Cw) · +2 | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Bone Graft Carrier 16cm Syringe SS 3.5mm · Bone Graft Carrier 16cm Syringe SS 4.5mm · Bone Graft Carrier 16cm Syringe SS 5.5mm · Bone Graft Carrier 16cm Syringe SS 7mm · +2 | — | — |
| Guilin Veirun Medical Technology Co., Ltd. | China | Maker | Endo Ultra Activator (Model: DA-1) | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | CanalPro Colored Syringe · Dental Irrigation Syringe · Dental Needle · Endodontic Treatment Use · +6 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Practicon, Inc. | United States | Maker | Pike Anesthetic Syringe | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | DENTAL SYRINGE | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Syringe | — | — |
| Pomee Corporation | Pakistan | Maker | Aspirating Syringes | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Dental Syringe · Impression Syringe · Irrigation Syringe | — | — |
| Medcave Private Limited | Pakistan | Maker | Syringe Periodontic | — | — |
| Panorama International | Pakistan | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Disposable dental impression syringe | — | — |
| Lacigrus International | Pakistan | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | SYRINGE PERIODONTIC ENDODONTIC IRRIGATING | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | disposable pre-bent needle tips · Disposable Syringe Tips, Disposable Air/Water Syringe Tips · Endodontic Irrigation Syringe · Flowable Composite and Etching Gel Tips · +4 | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | CanalPro color syringes · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | HILBRO INSTRUMENTS IRRIGATION · PERDIODONTIC SYRINGE · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| G.A. Surgical (Pvt.) Ltd. | Pakistan | Maker | Dental aspirating syringes | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Dental Syringes | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | disposable dental irrigation needles/ dental needle/ dental syringe · Pre Bent Needle Tips, Mixing Tips, irrigation syringe | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Pre Bent Needle Tips, Mixing Tips, irrigation syringe,dental needle | — | — |
| Silver Plus Corp. | Pakistan | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Disposable dental syringe | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | SYRINGE · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Lohar Medical Company | Pakistan | Maker | EIC / SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Pre Bent Needle Tips, Mixing Tips, irrigationsyringe,dental needle | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Produits Dentaires SA | Switzerland | Maker | IrriFlex · Plastic Pipettes | — | — |
| Daddy D Pro | Pakistan | Maker | Irrigation Syringes | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Dental needle | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | — | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Pre Bent Needles, Flow Tips, Irrigation Syringes with Curved Tip | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Mixing Tips, Pre Bent Needle Tips, Irrigation Needle, Dental Needle | — | — |
| SGS Export Intl. | Pakistan | Maker | Syringe, Periodontic, Endodontic, Irrigating | — | — |
| Dr Frigz International Pvt Ltd | Pakistan | Maker | DENTAL SYRINGE | — | — |
| Hager & Werken | Germany | Maker | MIRAJECT ENDO RINSE | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | IRRIGATION SYSTEM | — | — |
| Med2B Ltd. | Germany | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING, DENTAL SYRINGES | — | — |
| Hubei Qianjiang Kingphar Medical Material Co Ltd | China | Maker | Pre Bent Needle Tips, Mixing Tips, Irrigation Syringe, Dental needle | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Syringes, Irrigating, Endodontic syringes, Periodontic syringes, Luer Lock | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Syringe, periodontic, endodontic, irrigating | — | — |
| Alvi Expo | Pakistan | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Bethel Co., Ltd. | Japan | Maker | Irri-Tip 25 double side vent · Irri-Tip 27 double side vent · Irri-Tip 30 double side vent · Septodont Precision Tips · +12 | — | — |
| Ghousia Amanat Surgical | Pakistan | Maker | Aspirating Syringe Type C | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Capillary Tip, 3 Way Air Syringe, Air Water Syringe, Saliva Ejector · Disposable Irrigation Needle, Irrigation Syringe System, Disposable Dental Syringe, Pre-Bent Needle Tip, | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | — | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| United Dental Changzhou | China | Maker | Irrigation needles | — | — |
| Swengg Co | Pakistan | Maker | Dental Syringe Irrigation | — | — |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | China | Maker | Empty Plastic Syringes for dental materials filling · Plastic Capillary tips · Plastic Syringe Caps | — | — |
| Shanghai Greeloy Industry Co., Ltd | China | Maker | Dental Syringe | — | — |
| Sobytek Instruments Co. | Pakistan | Maker | SYRINGE | — | — |
| Denbur Inc | United States | Maker | C-Flow, EZ-Flow, Den-Flow | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| PAJUNK GmbH Medizintechnologie | Germany | Maker | PLURAJECT · UNIJECT · VARIOJECT · VARIOSAFE | — | — |
| STS Corporation | United States | Maker | Syringe, Periodontic, Endodontic, Irrigating - AMTC-K - EIC 1, Dental Hand Instrument | — | — |
| Xiamen Zhiyuan Medical Technology Co.,Ltd | China | Maker | Surgical Aspirator Tips, AirWater Syringe Tip | — | — |
| Jiangsu Caina Medical Co., Ltd | China | Maker | Syringe | — | — |
| Welmed, Inc. | United States | Maker | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | — | — |
| Medical Devices (PVT) LTd. | Pakistan | Maker | CARTRIDGE DENTAL SYRINGE | — | — |
| Ondine Biomedical Inc. | United States | Maker | Periowave 1ml photosensitizer | — | — |
| Pharmaphd II, LLC | United States | Maker | PERIOER | — | — |
| SAHIROUN (PVT) Ltd. | Pakistan | Maker | CARTRIDGE SYRINGE ALL TYPES | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Goldstar Medical Instruments | Pakistan | Maker | — | — | — |
| Meiban Micro Pte Ltd | Singapore | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| PT. Top-Point Medical | Indonesia | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| Wuxi Yushou Medical Appliances Co Ltd | China | Maker | — | — | — |
| Sybron Dental Specialties | United States | Contract manufacturer | ZenSeal Pro ZenSave Trimmable Tips · ZenSeal Tips | 203 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Innovative Bioceramix, Inc. | Canada | Manufacturer | BC Tips 15P | 8 | 2023 |
| NuSmile, Ltd. | United States | Manufacturer | Avalon Biomed Basic Flex Tips · Avalon Biomed Clear Flex Tips · Avalon Biomed Navi TIps · Avalon Biomed NeoSEALER EZFlo 29-gauge Dispensing Tips · +5 | 2 | 2026 |
| Biomet Microfixation | United States | Manufacturer | Aquafix Syringe · Aspirating Syringe · Syringe | 8 | 2021 |
| COLTENE Holding AG | Switzerland | Contract manufacturer | CanalPro Color Syringes | 1 | 2003 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Contract manufacturer | Komet BioSeal Flex Tips | 1 | 2007 |
| Engineered Endodontics | United States | Repacker / relabeler | Irrigator | 1 | 2019 |
| SS White Burs LLC | United States | Manufacturer | Syringe, Periodontic, Endodontic, Irrigating - SS Bioceramic Root Canal White Automix Tips | 1 | 2008 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Dispensing Gun, Composite Unidose/Compule · Valdent USA Disposable Air/Water Syringe Tips, Clear · Valdent USA Endodontic Irrigation Needle, 27ga, 3cc, Yellow | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Disposable Utility Syringe | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Pre Bent Needle Tips, Mixing Tips, Irrigation Syringe, Dental Needle | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Endodontic Syringe with Irrigation Needle | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Composite dispensing | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | Edge® | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DiaFlex | — | — |
| GoldenDent | United States | Repacker / relabeler | Irriflex Endo Irrigation | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Disposable Utility | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Z-Rinse | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| battech | United States | Repacker / relabeler | Pre Bent Needle Tips, Mixing Tips, irrigation syringe, dental needle | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Disposable Dental Syringe | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Curved Utility Syringe, Syringe, pre-bent needle tips ,Endodontic Irrigation Syringe | — | — |
| Midwest Dental | United States | Repacker / relabeler | — | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| simex Medizintechnik GmbH | Germany | Repacker / relabeler | Syringe, Periodontic, Endodontic, Irrigating | — | — |
| DeRoyal Industries Inc | United States | Contract manufacturer | Syringe, Periodontic, Endodontic, Irrigating - DeRoyal | — | — |
| CBR Enterprise Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| Global-Tec Enterprises, Inc. | United States | Repacker / relabeler | Jiangyin | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 30 Jun 1997 | K972234 | RCT GEL ROOT CANAL THERAPY GEL | Dentsply Intl., Inc. |
| 18 Nov 1986 | K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | Smith & Nephew, Inc. |
| 26 Jun 1986 | K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Solar Dental Co., Inc. |
| 1 Jul 1985 | K851944 | MAX-I-PROBE HANDPIECE | Solo Pak Laboratories |
| 5 Apr 1984 | K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Smith & Nephew, Mpl Division |
| 24 Jul 1981 | K811889 | R & S SERIES FITTING TOOLS | Suncoast Dental Corp. |
| 15 Jul 1981 | K811594 | WATER PISTOL | Aus-Tex Dental Mfg. & Design |
| 21 Jul 1980 | K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | National Patent Development Corp. |
| 21 Jul 1980 | K801483 | MARK IV SYRINGE | National Patent Development Corp. |
| 4 Jan 1980 | K792578 | EPIC CANNULA | Dental Development Services, Inc. |
| 4 Jan 1980 | K792577 | ENDOVAGE SYRINGE | Dental Development Services, Inc. |
| 19 Dec 1979 | K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Centrix, Inc. |
| 26 Aug 1977 | K771406 | GUTTA GUN | Aus-Tex Dental Mfg. & Design |
| 20 Jun 1977 | K770967 | SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE | National Patent Development Corp. |
| 20 May 1977 | K770813 | ENDOGATOR | Aus-Tex Dental Mfg. & Design |
| 15 Apr 1977 | K770642 | SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE | National Patent Development Corp. |
Official records: FDA product classification for EIC · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026