FDA.reportPublic FDA data

Waterpik Prophy Paste

Primary DI
D686200269310
Brand
Waterpik Prophy Paste
Company
WATER PIK, INC.
Model
20026931
Catalog number
20026931
Device description
Mint flavor, coarse grit
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D686200269313PrimaryHIBCC0
D686200269310Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight2Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 525-2020professional@waterpik.com

Regulatory Flags#

DUNS number
001804074
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10073950255551Handle/Hose Assembly Repair Kit20025555CC-01/02/04 HANDLE/HOSE ASSY REPAIR KIT (WHITE) (12026-03-13
10073950338223Waterpik Cordless Gem 5100 Water Flosser20033822WF-27CD0132026-03-13
00100739503237WaterPik Sensonic Toothbrush Brush Heads (3pk)20033042STWB-3EW-B2026-03-03
00100739503381Waterpik Cordless Gem 5100 Water Flosser20033818WF-27CD0102026-02-03
00056310343870Waterpik Cordless 1000 Water Flosser (2pk)20034387WF-29C0112026-01-28
00056310343900Waterpik Cordless 1000 Water Flosser (2pk)20034390WF-29C0132026-01-28
00073950330046Waterpik Sensonic Complete CareCC-04CD010-1CC-04CD010-12024-02-13
00073950343589WaterPik Ultra Plus and Cordless Express Water Flosser Combo20034358WF-150W/WF-02W0102026-01-08
00073950038232WaterPik Cordless Select 5100 Water Flosser20033823WF-28W0102026-01-05
00073950342360WaterPik Cordless Plus 5000 Water Flosser (2PK)20034236WF-26W020/WF-26W0202026-01-05
00073950342438WaterPik Cordless Advanced 2.0 Water Flosser (6PK)20034243WP-589CD2026-01-05
00073950342773WaterPik Cordless 1100 Water Flosser (6 PK)20034277WF-30CD0122026-01-05
00073950000185WaterPik Promax Waterflosser20034476WF-232025-12-09
10073950337240WaterPik Promax Waterflosser 6PK20033724WF-232025-12-09
00073950335232Water Pik Ultra Plus Waterflosser20033523WF-150W2025-07-02
00073950335454WaterPik Ultra Water Flosser20033545WF-100W(S)2025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810184450009RodinPac-Dent, Inc.EJR2026-03-23
00810184450016RodinPac-Dent, Inc.EJR2026-03-23
00810184450023RodinPac-Dent, Inc.EJR2026-03-23
E241BW9100Cavex Prophy Paste RegularCavex Holland B.V.EJR2026-03-11
E241BW9110Cavex Prophy Paste FineCavex Holland B.V.EJR2026-03-11
00883205042835OpalustreULTRADENT PRODUCTS, INC.EJR2026-03-10
10190707191174Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310231029993ProphyCare HApDirecta ABEJR2025-09-01
00348783012989Enamel Pro® Prophy PastePREMIER DENTAL PRODUCTS COMPANYEJR2025-07-16
00304040192771Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
06971560453466REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453473REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453480REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453497REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453503REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
D0337884100Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D0337884110Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D950116471PastelLARES RESEARCHEJR2025-05-02
D950116481PastelLARES RESEARCHEJR2025-05-02
00359883003081Contours™ Coarse Anatomy Trimmers Shape 05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003098Contours™ Coarse Anatomy Trimmers Shape 06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003104Contours™ Coarse Anatomy Trimmers Shape 08DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003111Contours™ Course Anatomy Trimers Starter KitDEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003500D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003517D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003524D-Fine™ Diamond Polishers for Hybrid Composites Diamond Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003609D-Fine Double Diamond™ Primary Polisher Refill #04DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003616D-Fine Double Diamond™ Primary Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003623D-Fine Double Diamond™ Primary Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003630D-Fine Double Diamond™ Primary Polisher Refill #08DEN-MAT HOLDINGS, LLCEJR2025-03-12