FDA.reportPublic FDA data

Colgate PreviDent Varnish Raspberry

Primary DI
00038341330395
Brand
Colgate PreviDent Varnish Raspberry
Company
COLGATE ORAL PHARMACEUTICALS, INC.
Model
733098
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
10038341330392PackageGS112In Commercial Distribution
00038341330395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003834133039210038341330392
00038341330395000383413303950383413303950038341330395

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
00038341330388Colgate PreviDent Varnish Mint7330962016-09-15
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
00035000983749Colgate Profesional Sensitivity Relief Serum TubeUS06793A2021-01-18
10035000970869Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20827854027120Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
20827854027571Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
506058610873033M™ Clinpro™3M COMPANYLBH2025-10-15
10818207025064ReminGelVista DentalLBH2025-10-09
07615208299373Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10
07615208292893Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-03-20
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
07615208474459Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-04-05
07615208474091Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-03-25
106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839703M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839873M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839943M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840073M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840143M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840213M™ Clinpro™3M COMPANYLBH2023-12-14
10810111542873FluoroCalBISCO INC.LBH2023-12-11
10810111542897FluoroCalBISCO INC.LBH2023-12-11
10371347011590Advance Dental ProductsThe Atlanta Dental Supply CompanyLBH2023-11-29
10732224005550Sparkle V Sodium Fluoride Varnish, CherryCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005567Sparkle V Sodium Fluoride Varnish, CaramelCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005574Sparkle V Sodium Fluoride Varnish, MelonCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224000302Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
10732224000319Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste TOM'S OF MAINE, INC.LBH2023-06-02
20810063753928Safco CleanCare Essential Prophy PasteSAFCO DENTAL SUPPLY CO.LBH2022-12-02