FDA.reportPublic FDA data

Hexa

Primary DI
00850079280151
Brand
Hexa
Company
Hexa Dental
Model
HV-4001
Device description
Hexa Varnish, 5% Sodium Fluoride Varnish Mint Flavor 0.4ml , 50/Pk
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850079280151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850079280151008500792801518500792801510850079280151

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
096955608
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057092158HexaHT-00042026-03-04
00850079280014One PlusJB-00142026-03-04
00850079280069Turbo EdgeTurbo-3162026-03-04
00850079280083Turbo EdgeTurbo-3122026-03-04
00850079280274Sure CordSure Cord Plus 12026-03-04
00850032750158HexaHT-0004HT-00042026-01-12
00008579280274sure EndoSure-Cord Plus 12026-01-22
00008579280083Turbo edgeTurbo-3122026-01-21
00085007928014One PlusJB-00142026-01-21
00085007928069Turbo EdgeTurbo-3162026-01-21
00850079280182Sure EndoSure-Cord 0002026-01-22
00850079280199Sure EndoSure-Cord 002026-01-22
00850079280205Sure endoSure- Cord 02026-01-22
00850079280212Sure EndoSure-Cord12026-01-22
00850079280229Sure endoSure-Cord 22026-01-22
00850079280236Sure EndoSure Cord Plus 000.02026-01-22
00850079280243Sure EndoSure-Cord Plus 0002026-01-22
00850079280250Sure Endosure-Cord Plus 002026-01-22
00850079280267Sure EndoSure -Cord Plus 02026-01-22
00850079280281SDure endoSure-Cord Plus 22026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00858290006628Advantage Arrest ELEVATE ORAL CARE, LLCPHR2020-12-21
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