FDA.reportPublic FDA data

Advantage Arrest

Primary DI
00858290006628
Brand
Advantage Arrest
Company
ELEVATE ORAL CARE, LLC
Model
Ampoule- 50 pk International
Catalog number
635IN5000
Device description
Advantage Arrest Silver Diamine Fluoride 38% 50 pk ampoule
Published
2020-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHRDiammine Silver Fluoride Dental Hypersensitivity VarnishDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102973000SILVER DENTAL ARRESTCooley Consulting, Inc.2014-07-31PHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858290006628PrimaryGS10
00858290006161Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858290006628008582900066288582900066280858290006628
00858290006161008582900061618582900061610858290006161

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.

Contacts#

Phone, Email table
PhoneEmail
877-866-9113info@elevateoralcare.com

Regulatory Flags#

DUNS number
002863526
Device count
50
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
00850079280151HexaHexa DentalPHR2026-01-21
00850079280168HexaHexa DentalPHR2026-01-21
00302730003383Young DentalYOUNG DENTAL MANUFACTURING I, LLCPHR2025-09-05
00858290006802Advantage ArrestELEVATE ORAL CARE, LLCPHR2025-07-21
00858290006819Advantage ArrestELEVATE ORAL CARE, LLCPHR2025-07-21
00858290006826Advantage ArrestELEVATE ORAL CARE, LLCPHR2025-07-21
00858290006956Advantage Arrest ELEVATE ORAL CARE, LLCPHR2025-06-11
00810118104503NuSmile NuNamel 38% Silver Diamine Fluoride (SDF)NUSMILE, LTD.PHR2025-03-10
00810118104510Avalon Biomed 38% Silver Diamine Fluoride (SDF)NUSMILE, LTD.PHR2025-03-10
00302730003307Young DentalYOUNG DENTAL MANUFACTURING I, LLCPHR2025-03-07
00817051023625SilverSenseCENTRIX, INC.PHR2023-12-13
00817051023632SilverSenseCENTRIX, INC.PHR2023-12-13
00858290006888Advantage Arrest ELEVATE ORAL CARE, LLCPHR2023-07-21
00850023750570Hexa DentalHexa DentalPHR2022-02-09
00850023750587Hexa DentalHexa DentalPHR2022-02-09
00858290006604Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
00858290006611Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
00858290006161Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
00858290006130Advantage ArrestELEVATE ORAL CARE, LLCPHR2016-11-01
00858290006000Advantage ArrestELEVATE ORAL CARE, LLCPHR2016-09-26