FDA.reportPublic FDA data

Colgate PreviDent Varnish Mint

Primary DI
00038341330388
Brand
Colgate PreviDent Varnish Mint
Company
COLGATE ORAL PHARMACEUTICALS, INC.
Model
733096
Device description
Colgate PreviDent Varnish 5% Sodium Fluoride has a strong desensitizing action when applied to dental surfaces treating hypersensitivity quickly and easily. This product sets rapidly on contact with saliva, resulting in patient comfort and acceptance. PreviDent will leave a thin film on the teeth after application.
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10038341330385PackageGS112In Commercial Distribution
00038341330388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003834133038510038341330385
00038341330388000383413303880383413303880038341330388

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizing, professionalA substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-962-2345xx@xx.xx

Regulatory Flags#

DUNS number
968801118
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00035000990754Colgate Optic White Professional Take-Home Whitening Kit610125612023-06-08
00827854000587Colgate Optic White Professional In Office Whitening Kit610201172023-06-08
00301260033228Colgate Optic White Professional Take-Home KitLWT32026-01-26
10301260033218Colgate Optic White Professional Take-Home KitLWT32026-01-26
00035000465214Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14
00035000977786Colgate Profesional Sensitivity Relief Serum TubeUS06793A2021-01-18
00035000465467Colgate Anywhere Anytime Sensitivity Relief SerumUS05495A2018-05-31
00035000466426Colgate Prorelief Sensitivity Relief SerumUS05562A2018-05-31
00301260033211Colgate Optic White Professional In Office Whitening Kit610482812025-11-06
00035000985835Colgate Total FlossUS07353A2023-08-15
00038341330937Colgate PreviDent Varnish Grape 7330932016-09-15
00038341457955Colgate PreviDent Varnish Caramel SundaeUS05089A2018-05-31
00038341451168Colgate PreviDent Varnish Raspberry - unit doseUS04261A2019-04-08
10035000990751Colgate Optic White Professional Take-Home Whitening Kit610125612023-06-08
00038341330395Colgate PreviDent Varnish Raspberry7330982016-09-15
00035000983749Colgate Profesional Sensitivity Relief Serum TubeUS06793A2021-01-18
10035000970869Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14

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