Surgical devices · 21 CFR 872 Subpart E
Irrigating (Dental) Syringe
FDA device type “Syringe, Irrigating (Dental)”.
- Companies listing it
- 6746 makers
- Brands and models
- 89
- 510(k) clearances
- 40 in five years
- FDA name
- Syringe, Irrigating (Dental)
510(k) clearances per year, 1976–2026
Companies that list EIB
67 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Den-Mat Holdings, LLC | United States | Maker | — | 8 | 2026 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Dental Anesthesia Injector, Ultrasonic Cleaning Unit, Sonic activation Unit | 1 | 2025 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co., LLC | 8 | 2012 |
| Shenzhen Yunding Information Technology Co.,Ltd. | China | Maker | Oclean AirPump Nozzle · Oclean AirPump Water Flosser · Oclean N1 · Oclean N10 · +25 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Dental Anesthesia Injector, Ultrasonic Cleaning Unit, Sonic activation Unit | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Syringe, Irrigating (Dental) | — | — |
| Endo Tech Instruments | Pakistan | Maker | Dental Syringes | — | — |
| Medcave Private Limited | Pakistan | Maker | Syringe Irrigating | — | — |
| Lacigrus International | Pakistan | Maker | PROBE, PERIODONTIC | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | Aspirating syringes | — | — |
| Surgicrafts | Pakistan | Maker | EIB - Syringe, irrigating (dental) | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Curved Syringe | — | — |
| Maryam Trading | Pakistan | Maker | SYRINGE, DENTAL | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Air/Water Syringe Tips | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Dental Curved Syringes | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Syringe, irrigating (dental) | — | — |
| Guangdong Yingxin Technology Co., Ltd. | China | Maker | oral irrigator | — | — |
| Mount Blonck Trading | Pakistan | Maker | Dental syringe | — | — |
| Teleflex | United States | Maker | MULTIPLE IRRIGATING DENTAL SYRINGES · PILLING | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Boen Healthcare Co Ltd | China | Maker | Dental Irrigating Syringe, Dental Irrigating Tips | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Dental Curved Syringes | — | — |
| Nicefeel Medical Device Technology Co.,Ltd. | China | Maker | FC2610,FC2660,2661,FC2690,FC2700,FC2720,FC2730,FC3810,FC3820,FC3830,FC3840,FC3850,FC3860,FC3870,FC3880,FC3890,FC158; · Nicefeel,FC168,FC259,FC2520,FC188,FC256,FC2680,FC188G,FC152,FC2581,FC158,FC2550,FC2550,FC169,FC2580; | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Irrigating Dental Syringe CHIRMED | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Painless Anaesthesia Device | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Syringe, Irrigating (Dental) | — | — |
| Waqas Surgical Instruments | Pakistan | Maker | Syringe, irrigating (dental) | — | — |
| Avilign Medical | Pakistan | Maker | Syringe, Irrigating (Dental) | — | — |
| Magenta Technology International Limited | China | Maker | Water Flosser; Dental Irrigator(XY10, TC01, TC03, TC05, L13, KX685, AOW04, AOW04PRO) | — | — |
| Skill To Tech International | Pakistan | Maker | Syringe, irrigating (dental) | — | — |
| Greatcare 4u sdn bhd | Malaysia | Maker | Disposable endo irrigation needles | — | — |
| Shantou Lula Plastic Products Co., ltd | China | Maker | Water flosser: LP033969, LP033970, LP033971, LP033972 | — | — |
| Jiangyin Nanquan Macromolecule Product Co Ltd | China | Maker | Dental Irrigating Syringe, Dental Irrigating Tips | — | — |
| Shenzhen Soga Technology Co. Ltd. | China | Maker | Electric Oral Anesthesia Injector · Smart I,Smart II,Smart III | — | — |
| STS Corporation | United States | Maker | Syringe, Irrigating, Dental - AMTC-K - EIB 1, Dental Hand Instrument | — | — |
| Ningbo Caremed Medical Products Co Ltd | China | Maker | Plastcare USA | — | — |
| Shandong Caremed Medical Products Co.,Ltd. | China | Maker | Syringe, irrigating (dental) | — | — |
| Shenzhen Junjiada Electric Appliance Co.,Ltd | China | Maker | Water flosser: H1,H2,H3 | — | — |
| TC Dental & Medical Supplies Inc | United States | Maker | starryshine | — | — |
| Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd. | China | Maker | Water Flosser | — | — |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., L | China | Maker | Dental Syrnge | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Camedical Technology (Cambodia) Co., Ltd. | Cambodia | Maker | — | — | — |
| CMT Health Pte. Ltd. | Singapore | Maker | — | — | — |
| Jedmed Instrument Co. | United States | Repacker / relabeler | JEDMED | 4 | 1981 |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Irrigating | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Curved Syringe with Graduation, 12 cc | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Endodontic Irrigation Needles | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | irrigating | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Curved Utility Syringe · MARK3® Luer Lock Endo Irrigation Syringe | — | — |
| WSD Labs Usa Inc. | United States | Repacker / relabeler | Syringe | — | — |
| Dukal Corporation | United States | Specification developer | Unipack Air/Water Syringe Tips | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | Irrigating Syringe | — | — |
| Oriental International Supplies Limited | Hong Kong SAR China | Foreign exporter | Irrigating Syringes | — | — |
| Vermont Manufacturing Services, Inc. | United States | Repacker / relabeler | Adventure Ready Brands | — | — |
| Zhejiang Medicines & Health Products Import & Expo | China | Foreign exporter | IRRIGATING SYRINGE, BULB SYRINGE, 50ML, 60ML, 100ML | — | — |
| BR Surgical LLC | United States | Repacker / relabeler | BR Surgical, LLC | — | — |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Contract manufacturer | — | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Shanghai Carelife International Trading Co. LTD | China | Foreign exporter | — | — | — |
| Shanghai Dynamic Medical Supplies Co., Ltd. | China | Foreign exporter | Syringe | — | — |
| U&U Medical Technology Co., Ltd | Hong Kong SAR China | Foreign exporter | Dental Syringe | — | — |
| Amnotec International Medical GmbH | Germany | Repacker / relabeler | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 20 Nov 1991 | K911118 | DTF-1000LL,DTF-1000 | Cp Medical |
| 14 Jan 1988 | K874543 | MODEL OPO-32 IRRIGATION SLEEVE | Allergan, Inc. |
| 12 Jul 1983 | K822411 | SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 | Western Advanced Technology, Inc. |
| 21 Sep 1976 | K760570 | ROBINSON MIDDLE EAR PROSTHESIS | Xomed, Inc. |
Official records: FDA product classification for EIB · 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