Miscellaneous devices · 21 CFR 872 Subpart G
Oral Irrigation Unit
FDA device type “Unit, Oral Irrigation”.
- Companies listing it
- 221182 makers
- Brands and models
- 949
- 510(k) clearances
- 470 in five years
- FDA name
- Unit, Oral Irrigation
510(k) clearances per year, 1976–2026
Companies that list EFS
221 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Inter-Med, Inc. | United States | Maker | — | 7 | 2026 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | DB-001 · DB-003 · DB-005 | 16 | 2026 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Sonic Activator: Wave 2, SoniWave, SoniFlow | 4 | 2022 |
| Shenzhen Micro Electric Intelligence Co., Ltd. | China | Maker | WD-XY-C01,WD-XY-C02,WD-XY-C03,WD-XY-C04,WD-XY-C05 | 1 | 2024 |
| Philips Medical Systems International BV | Netherlands | Maker | AirFloss · AirFloss Fill and Charge Station · AirFloss Pro · AirFloss Ultra · +8 | 16 | 2010 |
| Procter & Gamble | United States | Maker | — | 16 | 2020 |
| HT Co., Ltd. | South Korea | Maker | — | 1 | 2011 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | water flosser | 1 | 2020 |
| Seilglobal CO., Ltd | South Korea | Maker | Autoclavable Irrigation Tube | 1 | 2015 |
| Ronvig Dental Mfg. A/S | Denmark | Maker | AQUA-PRESS | 1 | 2006 |
| OnTel Products Corp | United States | Maker | Miracle Smile · Miracle Smile Head Pack MO · Water Flosser Head Pack MO · Water Flosser Replacement Heads · +1 | 1 | 1998 |
| Oratec Corp. | United States | Maker | Viajet | 1 | 1988 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | Dental Cleaning | — | — |
| Shenzhen Risun Technology Co., Ltd. | China | Maker | A5923; A5925; S620; S620 DELUXE OI100R OI-100R PLUS OI-200; S625-Deluxe Plus · A5925 · A5930 · A5999 · +94 | — | — |
| Guilin Veirun Medical Technology Co., Ltd. | China | Maker | Irrigation Device (Model: CX-H1) | — | — |
| Fly Cat Electrical Co.,Ltd. | China | Maker | A90-EU01-119719,4315,FC5260,A01-EU01-100061,A90-EU01-119717,FC163,4437 · ABOX, WELDENTAL,CLEAND, coolean, Sawgmore, Teethcon, Mysmile,ROSPEC · AC19,AC11,AC12,Apiker,MADY FC1591,ETEKECITY EWF-32,ETEKECITY EWF-32-RXT PETPO FC159 · ACLEON TF200,C300,D600,AL213, FJ-0628, Bopcal FC5570, FC5600,BR-AP1000 · +180 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | ORAL FLUSHERS Oral irrigation | — | — |
| Guangxi Hope Medical Devices Technology Co., Ltd. | China | Maker | Oral Irrigator XWYL-1701A · Oral Irrigator XWYL-1701B · Oral Irrigator XWYL-1701C · Oral Irrigator XWYL-1702A · +50 | — | — |
| Dental Studio | South Korea | Maker | EASY IRRIGATION TUBE | — | — |
| Shenzhen Fortunecome Technology Co.,Ltd. | China | Maker | FL-V16; FL-V17; FL-V18; FL-V19; FL-V20; FL-V22; FL-V23; FL-V24; FL-V26; FL-V27; · FL-V28; FL-V29; FL-V30; FL-V31; FL-V32; FL-V33; FL-V35; · FL-V36; FL-V41; FL-V42; FL-V43; · FL-V5; FL-V5-X1; FL-V6; FL-V8; FL-V8-X1; FL-V8L; FL-V9; · +8 | — | — |
| Risun Technology (Shenzhen) Limited | China | Maker | AS-ELITE-FLOS F5037 · AS-FLOS-PRO3, AS-ELITE-FLOS, AS-FLOS · AS-ICON-FLOS F5330 · BA-0160 · +23 | — | — |
| Scanderra GmbH | Switzerland | Maker | EW-WJ180 Flosserpik Power Spa · EW-WJ900 Flosserpik Lighthouse Oral Irrigator · EW-WJ950 Flosserpik Pro Station Oral Irrigator · EW-WJR2 Flosserpik WJ180 replacement tips set · +2 | — | — |
| Guangdong Xinbao Electrical Appliances Holdings Co.,Ltd | China | Maker | RTGX · RTGXRP · SWJ2CVSR · TB5031-ET · +17 | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Dental Irrigation Kit | — | — |
| Water Pik, Inc. | United States | Maker | Waterpik Aquarius Professional Water Flosser · Waterpik Aquarius Water Flosser · Waterpik Boost Tip · Waterpik Classic Jet Tip · +53 | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | Electric Dental Water Flosser | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Water flosser; Be Lucent Pulse water flosser | — | — |
| Shenzhen Relish Technology Co., Ltd | China | Maker | Calmdo, Merapure I Pro, Merapure I, vtooth, VT1b, WellSmile,U-PRETTY,Wangta, RLI541, SAQI, YB8120,marcopele,MP-KC01 · GM-01W,GM-01B,GM-01R,GM-01G,SHB-01W,SHB-01B,SHB-01R,SHB-01G,ST-01W,ST-01B,ST-01R,ST-01G,CPKT-01B,PL-10,PL-11,PLA · Newmana AC-202,RLI503,RLI504,RLI505,RLI506,RLI507,RLI509,DB01,Beautlinks,RKR OI-R,bionix RM00-7247,bionix RLI502, · Oral Surgery Partners, RLI504,CENSIY, PF3,Skara, RLI503,RLI504,RLI506,DR.BEI F1, DR.BEI GF1,STELLAR ST1,MD26SW,VEELLON · +6 | — | — |
| Shenzhen Baofengtong Electrical Appliances Manufacturing Co. | China | Maker | A6 · BT-01 · BT-02 · BT-03 · +34 | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Oral Irrigator | — | — |
| Providence Enterprise Limited | Hong Kong SAR China | Maker | Waterpik Aquarius Water Flosser · WaterPik Classic Jet Tip · Waterpik Classic Water Flosser · Waterpik Complete Care Sensonic · +24 | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Oral Irrigator | — | — |
| Ningbo Cooskin Stationery Co., Ltd. | China | Maker | C10 · C10S · C11 · C12 · +17 | — | — |
| Shenzhen Besman Electronic Technology Co., Ltd | China | Maker | Electronic port spray,ES-01,ES-02,ES-03,ES-05,ES-06, ES-08,ES-09,ES-10 · Oral Irrigator WT-168,WT-188,WT198,WT-218,WT-228,WT-258,WT-298,WT-312,WT-316,WT-318,WT-319,WT-321,WT-259, · TD-02, TD-03, TD-04, TD-05 · WT-268,WT-288 · +2 | — | — |
| Guangzhou Stars Pulse Co.,Ltd. | China | Maker | usmile C10 Portable Dental Flosser, models: C10 / C10 Blue / C10 White / C10 Inkstone Black / C10 Violet Mist · usmile C30 Portable Dental Flosser, models: usmile C30 / usmile C30 Shadow Black / usmile C30 usmile Blue / usmile C30 · usmile C30 SE Portable Dental Flosser, Models: USM111 Cloud White / USM111 Slate Black / USM111 Mist Pink · usmile C50 Portable Dental Flosser, models: usmile C50 / usmile C50 Bronze Gold / usmile C50 Obsidian Black · +3 | — | — |
| Iconbeauty (Shenzhen) Holding Ltd. | China | Maker | Electric dental flosser / Water flosser MWF-P7, MWF-P9, MWF-P11, WT-118, WT-118 Plus, WT-118 Extra, · OITB6000,13-33-002-08591-12,13-33-002-08609-12, 13-33-002-08610-12,IB3300,IB3380,13-33-001-08768-24, · S600, WT-228, WT-228Pro+, WT-238, WT-268, WT-288, WT-258, Electric Flosser S1, S9 · WH-188, WH-198,WH-298,TW-118,TW-128,TW-138,TW-148,TW-158,TW-168, TW-178,TW-188,TW-198,TW-298,OI1372, · +7 | — | — |
| Qibei Technology Co., Limited | China | Maker | H1S,H2S,H3S,H5S,JT100E,JT100,DT100E,OD100E,PP100E,PS100E,TB100E,TC100E,CL100,NW100,BT100,QA100,WF01,WF02,WF03 · Oral irrigator and replacement nozzle for irrigator Dental lrigator and irigator replacement nozzles | — | — |
| Dreame Technology Usa Inc. | United States | Maker | T01 Portable Water Flosser · T02 Pro UV Portabal Water Flosser · WT10 Water Flosser | — | — |
| TAO Clean | United States | Maker | BA-0160 · TAO Clean UV Water Flosser · TAO Clean Water Flosser | — | — |
| Ekong Technology Co., Limited. | China | Maker | water flosser/ portable water flosser / oral irrigator water flosser / mini water flosser/ electric water flosser | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Dental Polishing Motor | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Oral Irrigator, Water Flosser | — | — |
| Erskine Dental | Australia | Maker | Hydropik · Hydropik Mini · Hydropik Pro · Hydropik Ultra | — | — |
| Huzhou Junda Industry Co., Ltd. | China | Maker | Disposable irrigator | — | — |
| Yuanmeng Chuangzhi Technology(Shenzhen) Co.,Ltd. | China | Maker | T01 Portable Water Flosser · T02 Pro UV Portabal Water Flosser | — | — |
| Zhongshan BestClean Technology Co.,Ltd. | China | Maker | Household dental cleaner · Oral irrigator · Tooth cleaner · Water flosser | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Oral irrigator | — | — |
| Aimi Health Technology (Guangdong) Co., Ltd. | China | Maker | AO W29Pro, AOW30Pro, OCAN09plus, AOW09Plus · AOW02,AOW03,AOW04,AOW05,AOW06, AOW07,AOWO1Pro;AOW02Pro;AOW3Pro · AOW04Pro;AOW05Pro;AOW06Pro;AOW07Pro;EWF003 · AOW08, AOW09, AOW10, AOW11, AOW12, AOW08Pro; AOW09Pro; AOW10Pro; AOW11Pro · +4 | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Device Unit, Oral Irrigation | — | — |
| Shenzhen Jie Bishi Technology Co., LTD | China | Maker | D60,D80,D90,D10,D11,D12,D13,D14,D15,D16,D17,D18,D20,D30,D40,D50,D70 · Oral rinsing kit · W98,W99,W100,W200,W300,C3 Pro,C5 Pro,C8 Pro,C9 Pro,C2SE · water pik | — | — |
| Nicefeel Medical Device Technology Co.,Ltd. | China | Maker | coolean,CL-501,FC169; Cremax,CM-PCA001,FC1592; DOCSMEDI,TB5011SET(TB5011+TB5011-C),FC1596; · FLOOVER FC5091, FL-01 · HULMAY FC5170, P1, P1 PLUS, P2, P2 PLUS · MAYSEN,FC1591; medica+,Prowater Station 7,FC162,Prowater Clean 7,FC259; MEYARN,MY-M-007,FC1596,MY-M06-S1,FC2662; · +13 | — | — |
| Techtronic Trading Co. Ltd. | Hong Kong SAR China | Maker | CONAIR · HYDRO-PRO · HYDROFLOSS · INTERPLAK · +5 | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Cordless Oral Irigator/Cordless DentalFlosser, Teether, Nozzle Tips for Water Flosser · Oral irrigation unit/Dental Oral Irrigator, Water Flosser, DentalFlosser, Dental Water Jet, | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Unit, Oral Irrigation | — | — |
| Ashtel Studios, Inc. | United States | Maker | Soniclean, Water Flosser | — | — |
| Guangzhou Four E's Scientific Co., Ltd. | China | Maker | Irrigation Tubes | — | — |
| Shenzhen Yajiebao Technology Development Co., Ltd. | China | Maker | CY-1901; CY-1902; CY-1903; CY-1903B; CY-1904; CY-1905; CY-1906; CY-1907; CY-1908; CY-1909; CY-1910; CY-1911; CY-1912; · CY-1913; CY-1914; CY-1915; CY-1916; CY-1917; CY-1918; CY-1919; CY-1920; CY-1921; CY-1922; CY-1923; CY-1925; CY-1928; · CY-2202; CY-2203; CY-2205; CY-2206; CY-2207; CY-2208; CY-2209; CY-801; CY-803; CY-201; CY-202; CY-205; CY-206; · CY-820; CY-821; CY-825; CY-826; HF160A; HF175; HF176; HF190A; HF230A; W05; W05-1; W05-2; W06; OC1200 · +2 | — | — |
| Shenzhen YiGuangNian Innovation Technology Co., Ltd. | China | Maker | Oral Irrigator XPRE131 VCLL822 | — | — |
| Solite Wellbeing USA Inc. | United States | Maker | bixdo A30 Pro Ultra Compact Water Dental Flosser · bixdo A30 Ultra Compact Water Dental Flosser · bixdo K30 Smart Cordless Water Dental Flosser · bixdo M30 Ultra Compact Cordless Water Dental Flosser · +10 | — | — |
| Huizhou Gold Rose Technology Co.,Ltd | China | Maker | water flosser · WF100 · WF200 · WF300 | — | — |
| Risun Technology (Vietnam) Company Limited | Vietnam | Maker | AS-FLOS · AS-FLOS F5029 · F5020D F5028 F5023 F5020 F5108 F5530B1 F5530 F5010 RST5010 AS-KIDS-FLOS RST5002plus AS-FLOS-PRO-BK AS-FLOS-PRO-WH · F5025A, 711902, F5336 · +2 | — | — |
| Youshi (Xiamen) Sanitary Ware Industrial Co.,Ltd. | China | Maker | D0150, D0160, D0170, D0180, D0190, D0200, D0210, D0220, D0230, D0240, D0250, D0260, D0270, D0280, D0290, D0300, D0310, · D0320, D0330, D0340, D0350, D0360, D0370D, D0380, D0390, D0400, D0410, D0420, D0430, D0440, D0450, D0460, D0470, D0480, · D0490, D0500; · D1140, D1150, D1160, D1170, D1180, D1190, D1200, D1210, D1220, D1230, D1240, D1250, D1260, D1270, D1280, D1290, D1300, · +4 | — | — |
| Yangzhou Super J Toothbrush Co.,Ltd. | China | Maker | — | — | — |
| Shenzhen Balinda Technology Co.,Ltd | China | Maker | Nozzle Tips for water flosser · Oral Irrigator | — | — |
| Shenzhen Weijie Intelligent Technology Company Ltd. | China | Maker | Water flooser W01, W02, W03, W04, W05, W06, W07, W08, W09, W10, T1, T2, T3, T4, M50, M100, M150 · Water flooser: B1, B2, B3, B4, H1, H2, H3, H4, TD01, TD02, TD03, TD04, TD05, F500, F600, F700, F800, 310, 350 · Water flooser: X1, X2, X3, X4, X5, X6, X7, RV01, FG16690, TD03, TD05, TD06, TD07 | — | — |
| Euronda SPA | Italy | Maker | Irrigation Set For Machinery · Manual Irrigation Set · Tubing Extension For Mechanical Irrigation Set | — | — |
| Ningbo Beilun Kangyu Electrical Technology Co.,Ltd. | China | Maker | CY6108,CY6109, CY6111,CY6112 · CY6110 · CY6115, CY6116, CY6118, CY6119, CY6120, CY6121, CY6122 · CY6125,CY6126,CY6128,WF3400, M301,M4,M401,M402,M5,M9,M11,V2,V2k,V5,V6,V6k,E1,E2,E2k,E3,E5,E6,E6k,E6Pro,E7,E8,E9 · +1 | — | — |
| Omnia SRL | United States | Maker | IRRIGATION LINE | — | — |
| Shenzhen Samo Technology Co.,Limited | China | Maker | W900, F600-K, F700-K, F800-K · Water Flosser, F100, F200, F300, F400, F500, F600, F700, F800, F900, W100, W200, W300, W400, W500, W600, W700, W800, | — | — |
| Conquer Industry Co., Limited | China | Maker | Dental Water Jet · Oral Irrigation Unit · Oral Irrigator · Water Flosser · +1 | — | — |
| Flossom (GD) Beauty Technology Co., Ltd. | China | Maker | bixdo A30 Pro Ultra Compact Water Dental Flosser · bixdo NZ- bixdo A01 Orthodontic Tip · bixdo NZ-A01 Soft Tip · bixdo NZ-A01 Standard Tip · +5 | — | — |
| Ordo Club Limited | United Kingdom | Maker | ORDO HYDROSONIC WATER FLOSSER | — | — |
| Shanghai D-One International Co., Ltd. | China | Maker | Water pick flosser | — | — |
| Shenzhen Ainengke Electronics Co., Ltd. | China | Maker | electric teeth cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9 · household dental cleaner: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9 | — | — |
| BSD Product Design Inc. | Taiwan | Maker | Unit, Oral Irrigation | — | — |
| Dongguan MiQiang Technology Co., Ltd | China | Maker | Oral Irrigator XPRE131 Unit, Oral Irrigation | — | — |
| Omedic Technology (Dongguan) Co., Ltd | China | Maker | OMD01,OMD02,OMD03,OMD05,OMD06,OMD07,OMD08,OMD09,OMD10,OMD11,OMD12,OMD13,OMD15,OMD16,OMD17,OMD18 · Oral irrigator ,dental oral irrigator ,irrigator oral , dental water jet ,water flosser , dental water flosser, · water flosser pick,cordless oral irrigator,portable dental oral irrigator,dental jet,water dental pick,dental irrigator · XY02 | — | — |
| Providence Enterprise (Vietnam) Company Limited | Vietnam | Maker | WaterPik Aquarius Professional Water Flosser · WaterPik Aquarius Water Flosser · WaterPik Cordless Advanced 2 Water Flosser · WaterPik Cordless Pearl Water Flosser · +3 | — | — |
| Shenzhen Sinco Technology Co., Limited. | China | Maker | Oral Irrigator: 1001, 1002,1003, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1201, 1301, 1302, 1303, 1304, 1305 · Teeth Cleaner: J001, J002, J003, J004, J005, J006, J007, J008, J009, J010 | — | — |
| United Dental Changzhou | China | Maker | Irrigation needles | — | — |
| Cixi Seago Electronics Co.,ltd | China | Maker | — | — | — |
| Creative China Creations Ltd | Hong Kong SAR China | Maker | Advanced Clean Water Flosser Deluxe Pro · Miracle Smile · Miracle Smile Advanced Clean · Miracle Smile Head Pack MO · +3 | — | — |
| Dongguan Huachuangyoupin Electronic Technology Co., LTD | China | Maker | CQYBX-200D-G, 80686, W1, W9, C200, W1plus, U10/U20/U30, 2H1-A, 2H1-B, R-A31, R-A33, R-A34, R-A36, R-A39, R-A41, R-A43, · DX-04, S2, S5, S7, S7 PRO, S8, S80, W8, C30, GS-002, TB-2620, BR-SSN, PAROFLOSSER-01, CYQ300A-3A, CYQ300A-3, CQYBX-200D, · R-A49, R-B31, R-B33, R-B34, R-B36, R-B39, R-B41, R-B43, R-B49, C60, C70, 2H1 · WATER FLOSSER; Oral Irrigator: X3D, X3C, X3-A, X3-B, X3-C, X3-D, X3-AB, X3-BA, X3D2, X6-A, CX6, X7, X7A, X7B, X7-CA, · +3 | — | — |
| GuangDong Roman Technology Co., Ltd | China | Maker | ORAL IRRIGATION, MINI1 | — | — |
| Shenzhen Baotonghui Industrial Co.,Ltd | China | Maker | Water Flosser/Oral Irrigator | — | — |
| Dongguan Mingchuangyoushang Electronic Technology Co., Ltd. | China | Maker | ML8,ML9,ML10,ML15,ML16,ML17,ML18,ML19,ML20,T40,T50,T60,WFP17 · P13,P14,P15,P16,P17,P18,MLG1-S, Dental scrubber, · TX40,TX50,TX60,P11,P12,P50,P40 · Water Flosser P50,MLG1,MLG1-PIuS,MLG2,M6,M6PIuS,MS7,MS11,MS13,MS15,MS16,MS1 8,MS19,MS20,MS21,MS22,MS23,X22,X23,C2,C3,C4 · +1 | — | — |
| Jiangxi Risun Technology Co., Ltd | China | Maker | A5950 · BA-0160 · ORAL IRRIGATION D52-WE94 / D52-BK3 /D52-PK1 /D52-GN1 /F5106-WE3 | — | — |
| Shandong Richsource Biological Technology Co.,Ltd | China | Maker | Water Floss, Water Toothpick | — | — |
| Shenzhen Xiazhifeng Electronic Co., Ltd | China | Maker | Water flosser | — | — |
| Ningbo Raffini Import & Export Co., Ltd | China | Maker | Water Flossers Electric | — | — |
| Ningbo Raffini International Enterprise Limited | China | Maker | Water Flossers Electric | — | — |
| Poma Lifestyle Inc | United States | Maker | Invisalign Floss · Pomafloss | — | — |
| Rosemarie Products Company, LLC | United States | Maker | — | — | — |
| Shenzhen Topinnor Technology Co.,ltd | China | Maker | Water Flosser, model: DT01,DT02,DT03,DT04,DT05,DT06,DT07,DT08,DT09,DT10 · Water Flosser, model: HO01,HO02,HO03,HO04,HO05,HO06,HO07,HO08,HO09,HO10 · Water Flosser, model: PB01,PB02,PB03,PB04,PB05,PB06,PB07,PB08,PB09,PB10 · Water Flosser, model: PT01,PT02,PT03,PT04,PT05,PT06,PT07,PT08,PT09,PT10 | — | — |
| Wenzhou Charmhome Electronic Technology Co.,Ltd | China | Maker | Oral Irrigator · oral irrigator:AM301,AM302,AM305,AM306,AM308,CY20,CY01,CY02,CY03,CY05,CY06,CY07,CY08 ,CY09,CY10 | — | — |
| Ningbo kingworth global imp & exp co.,ltd | China | Maker | Powered Dental Flosser · Water Flosser | — | — |
| Osstem Pharma Co., Ltd. | South Korea | Maker | WO-200 Osstem Wopick Cordless Oral Irrigator · WO-300 Osstem Wopick Combo Irrigator & Sonic Toothbrush | — | — |
| Yuyao Rongda Plastic Industry Co., Ltd. | China | Maker | IRRIGATION ,WATER FLOSSER ,ORAL IRRIGATOR LC212,LC216,LC217 · Oral irrigator;Nasal Irrigator,nasal rinse packets | — | — |
| ZHEJIANG HUIFU INTELLIGENT HOME Furnishing CO.,LTD | China | Maker | IE018,IE008,CYQ01,CYQ02 | — | — |
| Dongguan Yipincheng Technology Co., Ltd. | China | Maker | Water Flosser W98 W99 W100 W200 W300 C3 Pro C5 Pro C8 Pro C9 Pro C2 C2SE C3 C3PRO C5 C5PRO C6 C6SE C6SE-BT C8 C10 | — | — |
| Global Best Way Co., Ltd. | China | Maker | Electric Dental Water Flosser · ORAL IRRIGATION UNIT | — | — |
| Hangzhou Yunchi Technology Co., LTD | China | Maker | Oral irrigator | — | — |
| Inwood Electronic Co., Ltd | China | Maker | Portable oral irrigator rechargable KAT,Water Flosser(Model:CBMD 3.7 A1) · Water Flosser (Model: NMD, 3.7, E10) | — | — |
| Jiangxi Royall Smart Technology Co., Ltd. | China | Maker | Oral Irrigator (Model: C2, C5, C6) · Water flosser (model: CL1, CL2, CL1(W), CL2(W)) | — | — |
| Ningbo Bair Home Appliances Co., Ltd. | China | Maker | M11Pro, M17-UV, M19, V1, V1Plus, V2, V2K, V2Pro, V3, V3Pro, V5, V6, V6K, V6Pro, H6, H7, E4, E4s, E6, E6s, E11, E11s · Water Flosser: M3, M3Plus, M301, M4, M401, M402, M4Pro, M4s, M5, M6, M6Plus, M6s, M7, M8, M9, M10, M10Plus, M11, M11s, | — | — |
| Ninghai Sunshine Commodity Co.,Ltd | China | Maker | NV-07081 RECHARGABLE WATER FLOSSER SILVER · NV-07082 RECHARGABLE WATER FLOSSER AQUA · NV-08455 ORAL FLOSSER · NV-08456 ORAL FLOSSER 2 · +2 | — | — |
| XiaMen Jieboya Technology Co.Ltd | China | Maker | W011XX(JR00302),W012XX(JR00102),W013XX(JR00002),W021XX(JY00300),W022XX(JY00100),W023XX(JY0000),W041XX,W042XX,W054XX,WJ15 · W061XX,W062XX,W071XX,W072XX,W091XX,W092,W092XX,W094,W094XX, GO-100, WJ14MN | — | — |
| Moon Oral Care, LLC. | United States | Maker | Water Flosser | — | — |
| Qingdao Jinpuguangyuan Science and Technology Co.,ltd | China | Maker | oral irrigator | — | — |
| Shanghai Shift Electrics Co.,ltd. | China | Maker | — | — | — |
| Shenzhen Hanasco Technology Co.,Ltd | China | Maker | Mouth Armor/MouthArmor Water flosser: H100 · Water flosser (hanasco, huacocare): H100, H200, H300, H400, H500, H600, H700, H800, H900 · Water flosser (hanasco, huacocare):H100 PLUS, H300 PLUS, H600 PLUS, C1 | — | — |
| Shenzhen Mlikang Technology Co., Ltd | China | Maker | M149,M149Pro,M149Art,M149Plus · Tooth Cleaning Machine M191,M191Pro,M192,M193,M194,M195,M196 · Water Flosser M209,M131,M139,M139Pro,M139Plus,M139Art,M141,M141Pro,M243,M249,M251,M252 | — | — |
| Twin River Group | United States | Maker | WATERPIK FLOSSER | — | — |
| Yuyao Clean Commodity Co.,ltd. | China | Maker | Water Flosser | — | — |
| Aboel Electronic Technology (Shenzhen) Co.,ltd | China | Maker | ABB886, ABB888, ABB889, ABB868, ABB869, ABB920, ABB921, ABB922, ABB924) · Water Flosser (ABB822, ABB823, ABB824, ABB825, ABB826, ABB880, ABB880D, ABB880S, ABB881, ABB882, ABB883, ABB884, ABB885, | — | — |
| Changzhou Freshday Household Products Corp. Ltd. | China | Maker | UNIT, ORAL IRRIGATION | — | — |
| CranioMandibular Rehab, Inc. | United States | Maker | Salvate | — | — |
| Hi-P (Xiamen) Precision Plastic Manufacturing Co., | China | Maker | quip Rechargeable Water Flosser | — | — |
| Jiangsu Longde Oral Care Company Limited | China | Maker | Water Flosser | — | — |
| Panasonic Wanbao Appliances Beauty and Living(Guangzhou) Co. | China | Maker | Oral Irrigator | — | — |
| QUIP NYC Inc. | United States | Maker | — | — | — |
| Seago Electronics(Thailand)co.,ltd | Thailand | Maker | WATER FLOSSER | — | — |
| Shenzhen Lunata Technology Co., Ltd | China | Maker | Electrical Tooth Cleaner With Water Pump,W06,W08, Water Flosser M209, M131, M139, M141, M151, tooth polisher P06, P08 | — | — |
| Shenzhen Yuechi Innovation Technology Co.,Ltd | China | Maker | OCJOY Air-Streaming HOME ORAL CLEANER Model: O1 · OCJOY Air-Streaming Oral Irrigation , Model Perlo Air1 | — | — |
| Yabeikang Technology (Dongguan) Co., Ltd. | China | Maker | Water flooser: V1/V2/V3/T1 | — | — |
| Yangzhou star oral care product co., ltd. | China | Maker | Perfct; Oralstar | — | — |
| Dongguan Jifan Electric Appliance Co., LTD | China | Maker | Water flosser, L5, L6, L8, L9, L10, L11, L12, L13, L15, C1, C2, C3, C5, C6, C7, C8, C9, C10, C20, C30 | — | — |
| Havenrock INC | United States | Maker | UNIT, ORAL IRRIGATION | — | — |
| Panasonic Manufacturing (Thailand) Co., Ltd. | Thailand | Maker | Oral Irrigator | — | — |
| Runner (Xiamen) Corp. | China | Maker | Waterflosser · Waterpik | — | — |
| Shenzhen Soocas Technology Co., Ltd. | China | Maker | — | — | — |
| SMD Solution Co., Ltd. | South Korea | Maker | Comoral H · Comoral Oral Irrigation Unit | — | — |
| Waterpulse (Jinhua) Biotechnology Co., Ltd | China | Maker | Unit, Water Flosser, Oral irrigator- Cordless water flosser (V200, V400Plus, V500, V580); · Water flosser (V300, V300G, V300R, V360, V600, V600G, V660, V700, V700Plus, V800) | — | — |
| Zhejiang Pusu Electric Appliance Co., Ltd. | China | Maker | Oral Irrigators, Irrigation, Tooth Washer, Water Jet | — | — |
| AIR FORCE LABS Inc. | United States | Maker | DENTAL AIR FORCE-HOME D | — | — |
| Bestway Plastic And Metal Products Ltd. | China | Maker | Water flosser, Model: BPF-01/BPF-02/BPF-03/BPF-04/BPF-05/BPF-06/BPF-07/BPF-08/BPF-09/BPF-10 · Water flosser, Model: BPF-11/BPF-12/BPF-13/BPF-14-BPF-15/BPF-16/BPF-17/BPF-18/BPF-19/BPF-20 | — | — |
| Conair LLC. | United States | Maker | CONAIR INTERPAK WATER TEST | — | — |
| Guangzhou Huaju Information Technology Co., Ltd | China | Maker | Oral irrigator ,dental oral irrigator ,irrigator oral , dental water jet ,water flosser , dental water flosser , | — | — |
| MS Vietnam Electronics Co., Ltd. | Vietnam | Maker | Compact Table Top Water Jet Rechargeable Portable Water Jet Model WJX01 WJ11CVSX WJ11X WJRP01 · Conair | — | — |
| Ningbo Jianjie Daily And Cosmetics Co., Ltd. | China | Maker | JJC205 | — | — |
| Panasonic Corporation of North America | United States | Maker | Panasonic | — | — |
| Parnell Pharmaceuticals Limited | United States | Maker | Mouth Kote Oral Rinse · MouthKote Oral Rinse | — | — |
| Runner Industry (Thailand) Co., Ltd. | Thailand | Maker | Water Flosser · Waterpik | — | — |
| Shenzhen Mericonn Technology Co., Ltd. | China | Maker | Water flosser (model: YF9506, FP10, SK-D, JC-D, JC-D1, SK-D2, JC-D2) | — | — |
| Shenzhen Ruiyi Business Technology Co., Ltd. | China | Maker | — | — | — |
| Shenzhen Ubrael Technology Co., Ltd. | China | Maker | WATER FLOSSER | — | — |
| Shenzhen Yuxinyuan Electronic Technology Co., Ltd. | China | Maker | Power Oral Irrigators:YXY-801,YXY-802,YXY-803,YXY-8031,Y820,YXY-821,Y201,Y201B,Y202,Y205,Y206,Y207,Y208,Y209,Y215 · YXY-880,Y881,Y825,Y826,P20,Y601,Y211,Y212,Y213,Y702, Y255 | — | — |
| Wenzhou Ezekiel Creative Electronic Technology Co., Ltd. | China | Maker | water flosser (cleans teeth, maintains teeth health, oral hygiene) | — | — |
| Wenzhou Xi Nan Electronic Technology Co., Ltd | China | Maker | Water Flosser | — | — |
| Xiamen Solex High-Tech Industries Co.,ltd | China | Maker | SL216 Water Flosser | — | — |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd | China | Maker | water flosser | — | — |
| ABrite Tech (Shanghai) Co.,Ltd | China | Maker | Oral Irrigator, Water Flosser model name: LP211, LP221, LP233, LP235 etc | — | — |
| ANCHIPLAST Srl | Italy | Maker | SET FOR DENTAL IRRIGATION | — | — |
| Complant Zhejiang Import & Export Co., Ltd. | China | Maker | Oral irrigator | — | — |
| Dongguan Shun King Company Limited | China | Maker | — | — | — |
| Fresh Health, Inc. dba Proclaim Health | United States | Maker | Proclaim Custom-Jet Oral Health System | — | — |
| Fuzhou Feiwo Trading Co.,Ltd | China | Maker | Water Jet Teeth Flossing | — | — |
| Global TV Concepts, Ltd. | United States | Maker | MSA Hydro | — | — |
| Guangdong EraClean Technology Co.,Ltd | China | Maker | EraClean,Portable oral irrigator,WF-T01,WF-T02,WF-T03,WF-T04,WF-T05,WF-T06,WF-T07,WF-T08 | — | — |
| H2OFLOSS.INC | United States | Maker | oral irrigator | — | — |
| HI-P (Thailand) Co.,Ltd | Thailand | Maker | QUIP Water Flosser | — | — |
| Hunan Accurate Bio-Medical Technology Co., Ltd. | China | Maker | Portable Oral Irrigator (model: TH2A3, TH2D4, TH2C3, TH2F3) | — | — |
| Jiangxi AICARE Medical Technology Co., Ltd | China | Maker | Oral irrigatorWT101,WT102,WT103,WT105,WT106,WT107,WT108 | — | — |
| Jinhua Qual-max Trading Co., Ltd | China | Maker | Oral Irrigator battery good | — | — |
| JOYTECH Healthcare Co Ltd | China | Maker | SEJOY Oral Irrigator | — | — |
| Miley Technology (Hebei) Co., LTD | China | Maker | Oral Irrigator model MLY-F001.MLY-F002.MLY-F003.MLY-F004.MLY-F005 | — | — |
| Neuralpulse Ltd. | United States | Maker | Water Dental Flosser WD01 | — | — |
| Ningbo Aolbea Oral Care Products Co., Ltd. | China | Maker | — | — | — |
| Onion Culture Industrial Co., Limited | Vietnam | Maker | ORAL IRRIGATOR, ONKY-6000 | — | — |
| Pintarmas Sdn Bhd | Malaysia | Maker | Hydro Station | — | — |
| ShenZhen BRAV Electronic Technologies Co., Ltd. | China | Maker | Water Flosser BV-609, BV-608, BV-212, BV-208, BV-210, BV-610, BV-611,BV-612,BV-520 | — | — |
| Shenzhen Future Electronic Co.,ltd | China | Maker | Oral irrigator, Water flosser, teeth cleaner | — | — |
| Shenzhen Shufang Electronic Commerce Co., Ltd. | China | Maker | Unit, Oral Irrigation ORALNEED | — | — |
| Yilian Yike (Shenzhen) Technology Co., Ltd. | China | Maker | Visual Oral Irrigator: HI-S1,HI-S2,HI-S3,HI-S4,HI-S5,HI-C1,HI-C2,HI-C3,HI-C4,HI-C5 | — | — |
| Assamed GmbH | Germany | Maker | — | — | — |
| In'Tech Industries | United States | Maker | — | — | — |
| K-One MediTech Sdn. Bhd | Malaysia | Maker | — | — | — |
| Klater (Hongkong) International Limited | China | Maker | — | — | — |
| Ningbo Seago Electric Co.,Ltd | China | Maker | — | — | — |
| Samson Innovation Corp. Ltd. | Hong Kong SAR China | Maker | — | — | — |
| Shenzhen Woodpecker Technology Co., Ltd. | China | Maker | — | — | — |
| Zhejiang Beauty and Health Electrical Appliance Co., Ltd. | China | Maker | — | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | Tube Extension | 148 | 2026 |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | ASSAmed GmbH - Medizinbedarf · ASSAmed Y-Connector · Irrigation Tube Elcomed · Irrigation Tubing Set · +1 | 94 | 2026 |
| W&H Dentalwerk Buermoos GmbH | Austria | Contract manufacturer | — | 17 | 2026 |
| KaVo Dental GmbH | Germany | Contract manufacturer | 109.8757 - Tube Set S600 | 2 | 2021 |
| Ranir, LLC | United States | Foreign exporter | HydroClean | 2 | 2011 |
| Silfradent srl | Italy | Foreign exporter | IRRIGATION LINE | 1 | 2009 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Exel Inc. dba DHL Supply Chain (USA) | United States | Repacker / relabeler | Waterpik | — | — |
| Medline Industries, LP | United States | Contract sterilizer | Medline | — | — |
| Ortho Dental Lab, LLC | United States | Manufacturer | SmileSet Premium Handheld Water Flosser · SmileSet Water Flosser Replacement Tips | — | — |
| Beaming White LLC | United States | Manufacturer | SnapWhite · Water Flosser | — | — |
| Boen Healthcare Co Ltd | China | Foreign exporter | Disposable irrigator | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Foreign exporter | Water flosser/Oral Irrigator | — | — |
| Bina Limited | Belize | Foreign exporter | Steri Irrigation Tips | — | — |
| Sterlab | France | Contract sterilizer | Accessories for oral irrigation, various tubes | — | — |
| Upper Canada Soap & Candle Makers Corporation | Canada | Foreign exporter | All About Men · Danielle · Danielle Creations | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | — | — | — |
| Guangzhou OO Medical Scientific Limited | China | Foreign exporter | OO Dental, Water Flosser | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Gurunanda LLC | United States | Contract manufacturer | — | — | — |
| Ningbo Chengyue Crafts Co.,ltd | China | Foreign exporter | Water Flosser | — | — |
| HYDY, Inc. | United States | Repacker / relabeler | Boka Power Flosser | — | — |
| Weldental LLC | United States | Repacker / relabeler | H2OFLOSS · WELFLOS | — | — |
| FedEx Supply Chain, Inc. | United States | Repacker / relabeler | UNIT, ORAL IRRIGATION | — | — |
| Yingjie Haotian (Guangdong) Electronic Technology Co., LTD. | China | Foreign exporter | Oral irrigator: XY01, XY02, XY03, XY05, XY06, XY07, XY09, XY10, XY12, XY13, XY15, XY16, XY18, XY19, XY20, XY21, XY22 · Oral irrigator: XY23, XY25, XY26, XY28, XY30, CL-502, XY1, CYQH004 | — | — |
| Beurer Far East Ltd. | Hong Kong SAR China | Foreign exporter | WF03 · WF13 · WF23 | — | — |
| Miniso Development Hong Kong Limited | China | Foreign exporter | Toothbrush | — | — |
| Amarigo Inc. | United States | Lister | Dental irrigator AOW01,AOW02,AOW03,AOW04,AOW05,AOW06, AOW07 · FC1591 | — | — |
| Easy Healthcare Corporation | United States | Repacker / relabeler | Easy@Home Water Flosser (EWF003 BLUE) · Easy@Home Water Flosser (EWF003) | — | — |
| Ryder Integrated Logistics, INC | United States | Repacker / relabeler | — | — | — |
| STS (Guangzhou) Trading Limited Company | China | Foreign exporter | UNIT, ORAL IRRIGATION | — | — |
| DMS HOLDINGS DBA HealthSmart International | United States | Lister | HealthSmart | — | — |
| Hong Kong Medsourcing Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
| Joicom Corporation | United States | Lister | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Rush Order | United States | Repacker / relabeler | — | — | — |
| STERIL VERONA s.r.l. | Italy | Contract sterilizer | — | — | — |
| Veenak International Limited | United Kingdom | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 11 Dec 2002 | K023232 | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE | Smartpractice |
| 25 Oct 2000 | K001493 | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. |
| 23 Dec 1998 | K983374 | AGATHA-A-H2010 | Midian Intl. |
| 10 Feb 1997 | K964810 | DERMADAM | Ultradent Products, Inc. |
| 31 Jul 1995 | K952234 | BARRIER ALL FILM | Cottrell, Ltd. |
| 9 Sep 1994 | K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | Procter & Gamble |
| 16 May 1994 | K923711 | PERIOFLEX TIP | Novadent, Ltd. |
| 25 Feb 1994 | K923937 | HYDRO FLOSS | Hydro Floss, Inc. |
| 20 Sep 1993 | K931380 | WATER PIK PLUS PLAQUE CONTROL SYSTEM | Teledyne Water Pik |
| 1 Sep 1992 | K923457 | SHOWERFLOSS | Summit Marketing Group, Inc. |
| 16 Jun 1992 | K922307 | SHOWERFLOSS ORAL IRRIGATION UNIT | Showerfloss, Inc. |
| 3 Jun 1992 | K921999 | INTERJET(TM) GINGIVAL CARE INSTRUMENT | Bausch & Lomb Incorporated |
| 30 Sep 1991 | K913030 | MAX-I-PROBE IRRIGATION SYSTEM | Smith & Nephew, Inc. |
| 17 Apr 1991 | K910832 | OXYFRESH OXYCARE 3000 | Oxyfresh |
| 15 Apr 1991 | K901955 | PERIOGARD(R) PERIOPEN | Colgate-Palmolive Company |
| 15 Feb 1991 | K905188 | PERIO PIK | Teledyne Water Pik |
| 25 Jan 1991 | K904850 | DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 | Micro Motors, Inc. |
| 6 Aug 1990 | K897053 | L'LL SQUIRT GUM ORAL RINSE DEVICE | James R. Powell |
| 21 Jun 1990 | K901600 | OSSEOTITE IRRIGATION UNIT | Collagen Corp. |
| 15 Jun 1990 | K900547 | WATER PIK(R) W/ADD'L CLAIMS | Teledyne Water Pik |
| 31 May 1990 | K900178 | ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES | Core-Vent Corp. |
| 15 May 1990 | K900991 | SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET | Tocad America, Inc. |
| 14 Feb 1990 | K896890 | DYNASURG DENTAL IRRIGATION SYSTEM | Micro Motors, Inc. |
| 1 Nov 1989 | K895259 | PIK POCKET(R), MODEL PP-3 | Teledyne Water Pik |
| 28 Aug 1989 | K894015 | WATER PIK(R) | Teledyne Water Pik |
| 5 May 1989 | K890600 | HYDRODENT ANTIPLAQUE SYSTEM | Hydrodent Laboratories, Inc. |
| 17 Mar 1989 | K884220 | AIR WATER SYRINGE TIP SHIELD | Steri-Shield Products, Inc. |
| 12 Aug 1988 | K882759 | PROFESSIONAL MODEL 7525 DELIVERY SYSTEM | Viadent |
| 23 Feb 1988 | K875150 | PERIODONTAL SCALING SOLUTION-C | Dentsply Intl., Inc. |
| 23 Feb 1988 | K875149 | PERIDONTAL SCALING SOLUTION-B | Dentsply Intl., Inc. |
| 23 Feb 1988 | K875132 | PERIODONTAL SCALING SOLUTION-A | Dentsply Intl., Inc. |
| 2 Jul 1987 | K864540 | PLAK VAK - PV-10 | Paul S. Barclay, D.D.S. , Ltd. |
| 26 Aug 1986 | K863131 | PIK POCKET (IRRIGATING TIP) | Teledyne, Inc. |
| 24 Jul 1985 | K852593 | SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273 | Northern Electric Co. Div. of Sunbeam Corp. |
| 8 Feb 1985 | K844339 | BRAUN DENTAL CENTER OC-3 | Procter & Gamble |
| 23 Nov 1984 | K844318 | ORAL IRRIGATION TIP | Pro Pulse, Inc. |
| 25 Apr 1984 | K840721 | PERIO PIK | Teledyne, Inc. |
| 30 Mar 1984 | K834545 | POCKETIP 4414 | Vipont Laboratories, Inc. |
| 31 Aug 1983 | K832223 | PERIODONTAL IRRIGATOR #7620 | Vipont Laboratories, Inc. |
| 31 Aug 1983 | K832222 | PRO PULSE PERIODONTAL IRRIGATOR 7618 | Vipont Laboratories, Inc. |
| 7 Jul 1983 | K831321 | GUM MACHINE | The Gum Machine Co. |
| 24 Nov 1982 | K823305 | DENTO SPRAY ORAL IRRIGATOR | Neo-Life Co. of America |
| 7 May 1982 | K813638 | MULTI-UNIT, MULTI-PURPOSE DEVICE | The Scott & Fetzer Co. |
| 27 May 1981 | K811175 | RECOH ROOT CANAL IRRIGATOR | Koei International, Inc. |
| 21 Apr 1981 | K810864 | WATER PIK ORAL HYGIENE CENTER | Teledyne, Inc. |
| 12 Nov 1980 | K802595 | ERGO IRRIGATION SYSTEM | Ergo Instruments, Inc. |
| 5 Mar 1980 | K800448 | WATER PIK TRAVELER, MODEL 79 | Teledyne, Inc. |
Official records: FDA product classification for EFS · 21 CFR 872.6510.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026