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Device Explorer · FDA GUDID · GMDN 63585

Water jet flosser

An electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available [non-prescription] over-the-counter (OTC) fo use in the

US‑registered devices92in commercial distribution
Companies15labelers on GUDID
Single‑use10%of device records
Sterile1%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Philips Oral Healthcare, Llc4347%
Shenzhen Brav Electronic Technologies Co., Ltd.910%
Shenzhen Risun Technology Co., Ltd.89%
Abrite Tech (Shanghai) Co., Ltd.67%
Ordoclub Ltd67%
Ortho Dental Lab Llc67%
Ningbo Cooskin Stationery Co., Ltd.55%
Medline Industries, Inc.22%

Top labelers

CompanyDevicesShare
Philips Oral Healthcare, Llc4347%
Shenzhen Brav Electronic Technologies Co., Ltd.910%
Shenzhen Risun Technology Co., Ltd.89%
Abrite Tech (Shanghai) Co., Ltd.67%
Ordoclub Ltd67%
Ortho Dental Lab Llc67%
Ningbo Cooskin Stationery Co., Ltd.55%
Medline Industries, Inc.22%
Shenzhen Xiazhifeng Electronic Co., Ltd11%
Shenzhen Achepower Electronic Co., Ltd11%
T Aesthetics Llc11%
Ihealth Labs Inc.11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

COOSKINMysmilePAKISSAchepowerRisuntechHANGSUNeclat essenceBRAVShinypikOrdoLuxPen Microneedling CartridgesSmileSet Premium Handheld Water Flosser – MintSmileSet Premium Handheld Water Flosser – BlackSmileDirectClub Water Flosser - BlackSmileDirectClub Water Flosser - WhiteSmileSet Water Flosser Replacement Tips - 4 pack

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 Irrigation51
EFSUNIT, ORAL IRRIGATION45
JEQTOOTHBRUSH, POWERED5
QAIPowered Microneedle Device1

GMDN & GCC registration

  • GMDN code 63585 · non‑implantable
  • Single‑use 10% · sterile 1% · Rx‑only 0% · OTC 65%
  • 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 water jet flosser products are registered in the US?

92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Water jet flosser", from 15 companies. The largest labeler is Philips Oral Healthcare, Llc with 47% of records.

Which FDA product codes apply?

EFS (Unit, Oral Irrigation), EFS (UNIT, ORAL IRRIGATION), JEQ (TOOTHBRUSH, POWERED), QAI (Powered Microneedle Device)

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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