FDA.reportPublic FDA data

Hexa Dental

Primary DI
00850023750587
Brand
Hexa Dental
Company
Hexa Dental
Model
HV-1001
Catalog number
HV-1001
Device description
Hexa 5% Sodium Fluride Varnish Bubblegum Flavors 5ml
Published
2022-02-09
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850023750587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023750587008500237505878500237505870850023750587

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(626)677-0486faraz@hygedentusa.com

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
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
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