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WATER PIK, INC.

United States·US-MF-000017734

Last updated September 17, 2026

What WATER PIK, INC. makes

The company manufactures oral hygiene devices, including manual and electric toothbrushes, water jet flossers, and sonic toothbrushes designed for home use. It also produces oral lavage systems, single-use dental impression trays, silicone dental impression materials, and dentifrice. Products like the Waterpik PowerPulse and Cordless Freedom Water Flosser are intended for plaque removal and gum stimulation, while the Sensonic Toothbrush combines sonic cleaning with water jet technology.

All listed devices fall under Class I regulatory classification in the EU and the US. The company’s products are registered in EUDAMED and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
1730 East Prospect Road, Fort Collins, United States
Website
waterpik.com
LinkedIn
—
Facebook
—
Phone
1-800-525-2774
PRRC Contact
Eric Rodriguez
EUDAMED SRN
US-MF-000017734
FDA FEI Number
1712259
DUNS Number
001804074

Catalogue (458)

Page 8 of 10
DeviceModel / ReferenceRegistriesClassStatus
Waterpik RainFall+ with PowerPulse XED-639E
FDA UDI
Class IActive
Waterpik PowerPulse YCN-635E
FDA UDI
Class IActive
Waterpik UltraClear Fluoride Varnish (Bubblegum) 20021256
FDA UDI
Class IIUnknown
Waterpik Ultra Plus and Nano Plus Water Flosser WP-152W/WP-322W
FDA UDI
Class IUnknown
Waterpik Complete Care Oscillating 5.5 WP-811W
FDA UDI
Class IUnknown
Waterpik Cordless Freedom Water Flosser WF-03CD010
FDA UDI
Class IActive
Waterpik Whitening Professional Water Flosser WF-05CD020
FDA UDI
Class IUnknown
Waterpik PowerPulse QMK-753ME
FDA UDI
Class IActive
Waterpik Complete Care Sensonic CC-04W027-1
FDA UDI
Class IUnknown
Waterpik Sidekick WF-04CD012-3
FDA UDI
Class IActive
Waterpik Cordless Pulse Water Flosser WF-20W010
FDA UDI
Class IActive
Waterpik PowerPulse XPB-769ME
FDA UDI
Class IActive
Waterpik Cordless Freedom Water Flosser WF-03CD012
FDA UDI
Class IActive
Waterpik PowerPulse XRO-733
FDA UDI
Class IUnknown
Waterpik Sensonic Toothbrush STW-03W020
FDA UDI
Class IActive
Waterpik PowerPulse with Qwik-Pause QTL-969MEP
FDA UDI
Class IActive
Waterpik RainFall+ with PowerPulse XMT-633
FDA UDI
Class IUnknown
Waterpik RainFall+ with PowerPulse XED-633E
FDA UDI
Class IActive
Waterpik Aquarius Water Flosser WP-660C
FDA UDI
Class IActive
Waterpik ION Water Flosser WF-11W010-1
FDA UDI
Class IActive
Waterpik Sonic-Fusion 2.0 Professional SF-04CD017-1
FDA UDI
Class IUnknown
Waterpik Key-To Alginate Impression Material 013126-000
FDA UDI
Class IIUnknown
Waterpik PowerPulse QMK-759ME
FDA UDI
Class IActive
Sonic Fusion SF-04W030-1
FDA UDI
Class IActive
Waterpik ShowerClean Pro with PowerPulse and PowerJET QCM-763E
FDA UDI
Class IUnknown
Waterpik Whitening Water Flosser WF-06W020
FDA UDI
Class IUnknown
Waterpik Cordless Revive Water Flosser WF-03W034
FDA UDI
Class IActive
Waterpik PowerPulse XDC-641VB
FDA UDI
Class IUnknown
Waterpik PowerPulse XAS-645ME
FDA UDI
Class IActive
Waterpik UltraThin Fluoride Varnish (Mint) 20026697
FDA UDI
Class IIUnknown
Waterpik UltraThin Fluoride Varnish (Melon) 20026690
FDA UDI
Class IIUnknown
Waterpik PowerPulse YAD-733HE
FDA UDI
Class IActive
Waterpik Sonic-Fusion 2.0 SF-03W042-2
FDA UDI
Class IUnknown
Waterpik Ultra Thin & Clear Varnish 20030671
FDA UDI
Class IIUnknown
Waterpik PowerPulse XFT-733
FDA UDI
Class IUnknown
Waterpik Sonic-Fusion 2.0 SF-03W032-2
FDA UDI
Class IUnknown
Waterpik Cordless Advanced Water Flosser WP-563CD
FDA UDI
Class IUnknown
Waterpik Cordless Pearl Water Flosser WF-13CD010
FDA UDI
Class IActive
Waterpik PowerPulse XAU-643E
FDA UDI
Class IActive
Waterpik Ultra Water Flosser WP-117W
FDA UDI
Class IUnknown
Waterpik HairWand with PowerPulse Spa System YPW-839E/SPW-489MED
FDA UDI
Class IActive
Waterpik Ultra Thin & Clear Varnish 20030676
FDA UDI
Class IIUnknown
Waterpik UltraThin Fluoride Varnish (Strawberry) 20026692
FDA UDI
Class IIUnknown
Waterpik PowerPulse XDC-649
FDA UDI
Class IUnknown
Waterpik ShowerClean Pro with PowerPulse and PowerJET QCM-769ME
FDA UDI
Class IActive
Waterpik ION Water Flosser WF-11W020-1
FDA UDI
Class IActive
Waterpik PowerPulse XRO-763E
FDA UDI
Class IActive
Waterpik Wizard Wedges 061205-000
EUDAMEDFDA UDI
Class IActive
Waterpik Sani-Trays Impression Tray 011526-012
EUDAMED
Class IActive
Waterpik Tra-Tens Impression Tray 13457-000
EUDAMED
Class IActive

Related Companies

Authorised Representatives

Importers

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Notified Bodies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

WaterPik, Inc. has two recall records listed in the FDA database, initiated on April 3, 2012, and July 2, 2018. Both recalls were subsequently terminated. The first involved a potential overheating issue with the charging base, which could lead to localized melting, sparking, or electrical hazards. The second was due to customer complaints about cross-contamination between the sinus rinse solution and the battery compartment.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Jul 2, 2018Z-2734-2018—terminated

Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.

Apr 3, 2012Z-1674-2012—terminated

Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.