FDA.reportPublic FDA data

Waterpik Ultra Thin & Clear Varnish

Primary DI
D686200306703
Brand
Waterpik Ultra Thin & Clear Varnish
Company
WATER PIK, INC.
Model
20030670
Catalog number
20030670
Device description
5% Sodium Fluoride, Bubblegum flavor
Published
2021-10-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040098000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040098000VARNISHAMERICAMedical Products Laboratories, Inc.2004-02-04LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D686200306703PrimaryHIBCC0
D686200306750Unit of UseHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.4Milliliter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
001804074
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00073950346788Waterpik Cordless Pulse 3100 Water Flosser20034678WF-2CD0152026-05-26
00073950347167Waterpik Cordless 1200 Water Flosser20034616WF-36W011(S)2026-05-26
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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

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