FDA.reportPublic FDA data

Waterpik UltraClear Fluoride Varnish (Melon)

Primary DI
D6862002125538
Brand
Waterpik UltraClear Fluoride Varnish (Melon)
Company
WATER PIK, INC.
Model
20021255
Catalog number
20021255
Device description
Fluoride Varnish, Box of 100 single dose (0.40ml) (Melon flavor)
Published
2016-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6862002125538PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity varnishA liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

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
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00073950333924Waterpik RainFall+ with PowerPulse YPW-833EYPW-833E2024-04-29
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