FDA.reportPublic FDA data

Waterpik Prophy Paste

Primary DI
D686200334950
Brand
Waterpik Prophy Paste
Company
WATER PIK, INC.
Model
20033495
Device description
PROPHY PASTE (BUBBLEGUM) (MEDIUM) (200PK)
Published
2025-01-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
D686200334950PrimaryHIBCC0
D686200334953Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Professional dental abrasive materialA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.

Regulatory Flags#

DUNS number
001804074
Device count
200
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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