FDA.reportPublic FDA data

VELLA 5% Sodium Fluoride Varnish Bubble Gum Case 12 Boxes 100

Primary DI
D024770115
Brand
VELLA 5% Sodium Fluoride Varnish Bubble Gum Case 12 Boxes 100
Company
Preventech
Model
770115
Catalog number
770115
Device description
VELLA 5% Sodium Fluoride Varnish Bubble Gum Case 12 Boxes 100 ea. 0.5mL unit dose packages
Published
2016-10-05
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140350000VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOLPreventive Technologies, Inc.2014-12-12LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D024770115PrimaryHIBCC0
770115Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and 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., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
704-849-2416customerservice@preventech.com

Regulatory Flags#

DUNS number
090735093
Device count
1200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D024772105VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 357721057721052016-10-05
D024772113VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 1007721137721132016-10-05
D024772115VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 1007721157721152016-10-05
D024772145VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 357721457721452016-10-05
D024772153VELLAmini 5% Sodium Fluoride Varnish Caramel Box 1007721537721532016-10-05
D024772155VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 1007721557721552016-10-05
D024772215VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 357722157722152016-10-05
D024772225VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 357722257722252016-10-05
D024772235VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 1007722357722352016-10-05
D024772245VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 1007722457722452016-10-05
D024772275VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 357722757722752016-10-05
D024772285VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 1007722857722852016-10-05
D024772103VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 357721037721032016-10-05
D024772143VELLAmini 5% Sodium Fluoride Varnish Caramel Box 357721437721432016-10-05
D024772213VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 357722137722132016-10-05
D024772223VELLAmini 5% Sodium Fluoride Varnish Strawberry Box 357722237722232016-10-05
D024772233VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 1007722337722332016-10-05
D024772243VELLAmini 5% Sodium Fluoride Varnish Strawberry Box 1007722437722432016-10-05
D024772273VELLAmini 5% Sodium Fluoride Varnish Melon Box 357722737722732016-10-05
D024772283VELLAmini 5% Sodium Fluoride Varnish Melon Box 1007722837722832016-10-05

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