FDA.reportPublic FDA data

Hexa

Primary DI
00850023750860
Brand
Hexa
Company
Hexa Dental
Model
HCS-1004
Catalog number
HCS-1004
Device description
Hexa Core , Dual Curing 3 in 1, Syr 6gm
Published
2023-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, tooth shade, resin
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850023750860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023750860008500237508608500237508600850023750860

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

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
00850079280441HygedentUSAHD10000HD100002026-01-12
00850079280465HygedentUSAHD10005HD100052026-01-12
00850079280472HygedentUSAHD10010HD100102026-01-12
00850079280489HYgedentUSAHD10015HD100152026-01-12
00850079280496HygedentUSAHD10020HD100202026-01-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456224373JMUJMU DENTAL, INCEBF2026-07-22
00840456224380JMUJMU DENTAL, INCEBF2026-07-22
00840456224397JMUJMU DENTAL, INCEBF2026-07-22
00840456224403JMUJMU DENTAL, INCEBF2026-07-22
00840456224410JMUJMU DENTAL, INCEBF2026-07-22
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07
07630243601301ParaCoreDent4You AGEBF2026-07-07
07630243634743ParaCoreDent4You AGEBF2026-07-07
07630243634750ParaCoreDent4You AGEBF2026-07-07
07630243634767ParaCoreDent4You AGEBF2026-07-07
07630243634774ParaCoreDent4You AGEBF2026-07-07
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02