FDA.reportPublic FDA data

FluoriMax Salted Caramel

Primary DI
10858290006229
Brand
FluoriMax Salted Caramel
Company
ELEVATE ORAL CARE, LLC
Model
Shipper
Device description
FluoriMax Varnish Flow Through Ampoule Salted Caramel Shipper
Published
2017-09-16
Public version status
Update
Distribution status
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
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
10858290006229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085829000622910858290006229

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
877-866-9113info@elevateoralcare.com

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

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10818207025064ReminGelVista DentalLBH2025-10-09
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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
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106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
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