Consulting Wallah › Device Explorer › Other devices › Oral lavage system
Device Explorer · FDA GUDID · GMDN 12304

Oral lavage system

An assembly of devices intended for automated or semi-automated irrigation and washing of tissue/debris from teeth, gums, and other parts of the oral cavity (e.g., tongue) through application of pulsed jets of non-medicated liquids (e.g., mouthwash, water), to

US‑registered devices130in commercial distribution
Companies18labelers on GUDID
Single‑use15%of device records
Sterile8%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Water Pik, Inc.7860%
Hygitech1310%
Gurunanda, Llc1310%
Guangzhou Stars Pulse Co., Ltd.32%
Supermouth Llc32%
Ascend Eagle Incorporated32%
Shenzhen Hanasco Technology Co., Ltd.22%
Joytech Healthcare Co.,Ltd22%

Top labelers

CompanyDevicesShare
Water Pik, Inc.7860%
Hygitech1310%
Gurunanda, Llc1310%
Guangzhou Stars Pulse Co., Ltd.32%
Supermouth Llc32%
Ascend Eagle Incorporated32%
Shenzhen Hanasco Technology Co., Ltd.22%
Joytech Healthcare Co.,Ltd22%
Easy Healthcare Corporation22%
D-M-S Holdings, Inc.22%
Stradis Medical Llc22%
Miley Technology (Hebei) Co., Ltd11%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ABOBOABOELSupersmileSejoy Oral IrrigatorSEJOYHYGITECHUsmileRose Gold Water FlosserBlue Water FlosserWhite Water FlosserGuruNanda Water Flosser H3200AGuruNanda Lion and Lamb KitGuruNanda Compact Water Flosser,GuruNanda Compact Water Flosser, HM100GuruNanda Kids Water FlosserGuruNanda Water Flosser R3100A

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EFSUnit, Oral Irrigation151
JEQToothbrush, Powered10
NRDUnit, Operative Dental, Accessories3
ELCScaler, ultrasonic2
OFXGeneral Purpose Dental Tray2
ECBUnit, Syringe, Air And/Or Water1

GMDN & GCC registration

  • GMDN code 12304 · non‑implantable
  • Single‑use 15% · sterile 8% · Rx‑only 2% · OTC 72%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many oral lavage system products are registered in the US?

130 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Oral lavage system", from 18 companies. The largest labeler is Water Pik, Inc. with 60% of records.

Which FDA product codes apply?

EFS (Unit, Oral Irrigation), JEQ (Toothbrush, Powered), NRD (Unit, Operative Dental, Accessories), ELC (Scaler, ultrasonic)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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