FDA.reportPublic FDA data

FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy

Primary DI
00858290006796
Brand
FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy
Company
ELEVATE ORAL CARE, LLC
Model
6301CC122
Device description
FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131376000SMARTCOAT 2.5% NAF VARNISHElevate Oral Care2013-08-27LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858290006796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858290006796008582900067968582900067960858290006796

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002863526
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858290006987Allday Oral Moisturizing Rinse, 10oz Bottle626MR10102026-05-01
00858290006970FluoriMax 2.5% NaF demo pack 630FMFT042026-01-28
00858290006802Advantage Arrest635GE30002025-07-21
00858290006819Advantage Arrest635GSP0502025-07-21
00858290006826Advantage Arrest635GSP0502025-07-21
00858290006956Advantage Arrest Advantage Arrest SDF 38% Gel Syringe 2.8ml Kit635GEL2802025-06-11
00858290006734FluoriMax Cotton CandyFlow Through Ampoule 70 pack6300070222024-12-12
00858290006918PapacariePapacarie Syringe610PAP1002024-12-12
00858290006932Povi-OnePovi-One/FluoriMax Varnish BG Convenience640POFM802024-12-12
00858290006659Elevate Tongue Cleaner Metal 6pk655METAL62021-07-28
00858290006444Smart Advantage GI Sample A1 and A2 pk675UD02002019-06-10
00858290006543Denteshield Primer 3ml Kit685PRM3002020-04-01
00858290006550Denteshield Primer 7ml Kit685PRM7002020-04-01
00858290006369Smart Advantage GI A1 ampule575CAPA1S2019-06-10
00858290006376Smart Advantage GI A2 ampoule575CAPA2S2019-06-10
00858290006352Smart Advantage GI A1 and A2 Combo kit 30 ampules675COMB002019-10-14
00858290006314Tooth Print Wafer Sample Pack660TPSAMP2019-05-30
00858290006031Elevate Tongue Cleaner Pink 655PINK002019-01-23
00858290006598DenteShield Sample Opaque with Fluoride 685DSSAMP2020-06-11
00858290006529DenteShield Pit and Fissure Sealant Kit with Fluoride Clear685PITFTC2020-04-01

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