FDA.reportPublic FDA data

Waterpik ION Professional Water Flosser

Primary DI
00073950315524
Brand
Waterpik ION Professional Water Flosser
Company
WATER PIK, INC.
Model
WF-12CD020-1
Catalog number
WF-12CD020-1
Device description
Compact cordless countertop water flosser, white
Published
2022-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFSUnit, Oral Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00073950315524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00073950315524000739503155240739503155240073950315524

GMDN Terms#

Term, Definition table
TermDefinition
Oral lavage systemAn 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 maintain oral hygiene; it may in addition be intended for nasal lavage. It consists of a central mains electricity (AC-powered) unit with a reservoir and pump, and a number of hand-held applicators, each typically designed to clean a specific oral anatomy (e.g., tongue, braces, gum line). It is normally available [non-prescription] over-the-counter (OTC) for use in the home and dental office.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-525-2774service@waterpik.com

Regulatory Flags#

DUNS number
001804074
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00073950345897Waterpik Cordless Enhance 3200 Water Flosser20034589WF-34W010(S)2026-05-26
00073950346122Waterpik Cordless Water Flosser20034612WF-35W017(S)2026-05-26
00073950346788Waterpik Cordless Pulse 3100 Water Flosser20034678WF-2CD0152026-05-26
00073950347167Waterpik Cordless 1200 Water Flosser20034616WF-36W011(S)2026-05-26
10056310971209Water Pik Revive with PowerPulse20034197-120CURV-563M2025-04-09
00073950337885WaterPik Transform RV with PowerPulsePHR-553EPHR-553E2025-01-29
00073950337960WaterPik Transform RV with PowerPulsePHR-559EPHR-559E2025-01-29
00073950338011WaterPik Transform RV with PowerPulsePHR-551EPHR-551E2025-01-29
00073950339230WaterPik Caddy Buddy with PowerPulsePHO-553MEPHO-553ME2025-01-29
00073950339322WaterPik Caddy Buddy with PowerPulsePHO-559MEPHO-559ME2025-01-29
00073950339346WaterPik Caddy Buddy with PowerPulsePHO-555EPHO-555E2025-01-29
00073950333689Waterpik PowerPulse with DualDockQMR-863MEQMR-863ME2024-04-29
00073950333726Waterpik PowerPulse with DualDockQMR-869MEQMR-869ME2024-04-29
00073950333924Waterpik RainFall+ with PowerPulse YPW-833EYPW-833E2024-04-29
00073950334303Waterpik PowerPulseXSP-755MEXSP-755ME2024-04-29
00073950333184Waterpik PowerPulseXFT-763MEXFT-763ME2024-04-02
00073950332996Waterpik RainFall+ with PowerPulse XED-633EXED-633E2024-03-15
00073950333122Waterpik PowerPulseYCN-635EYCN-635E2024-03-15
00073950328258Waterpik PowerPulseYDT-933EYDT-933E2023-08-14
00073950326896Waterpik ShowerCare with PowerPulseQBS-561MEBQBS-561MEB2023-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950345897Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346122Waterpik Cordless Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346788Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950347167Waterpik Cordless 1200 Water FlosserWATER PIK, INC.EFS2026-05-26
08809260475687Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
08809260475694Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
00056310343412WaterPik Cordless Plus 5000 Water FlosserWATER PIK, INC.EFS2026-04-09
08052141311806Irrigation LineOMNIA SRLEFS2026-03-27
08052141312025Irrigation LineOMNIA SRLEFS2026-03-27
08052141312780Irrigation LineOMNIA SRLEFS2026-03-27
08052141312865Irrigation LineOMNIA SRLEFS2026-03-27
08052141312940Irrigation LineOMNIA SRLEFS2026-03-27
08052141313602Irrigation LineOMNIA SRLEFS2026-03-27
00073950255554Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
00073950338226Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
00197344199764MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
00197344199771MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
10197344199778MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
00050428005408CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005415CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005422CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
05060640672406OrdoORDOCLUB LTDEFS2026-02-06
00073950338189Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
00100739503381Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
00056310343870Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
00056310343900Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
10073950278192Water Pik Ultra Waterflosser (3pk)WATER PIK, INC.EFS2026-01-12