FDA.reportPublic FDA data

Hexa

Primary DI
00850079280298
Brand
Hexa
Company
Hexa Dental
Model
HFE-0001
Device description
Hexa Freeze Endo Refrigerant Spray, Mint Scented, 10oz (283g)
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MLYVapocoolant Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLYVapocoolant DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850079280298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850079280298008500792802988500792802980850079280298

GMDN Terms#

Term, Definition table
TermDefinition
Cryogenic spray, dentalA liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. 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
10723797170615InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170721InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170837InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170943InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797806446Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797807443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797809447Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797806443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797807440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797808440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797809444Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
00860010587355DentalJect ApplicatorVapocoolshot, IncMLY2025-11-07
00860010587362DentalJect Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587393DentalJect Starter Kit - No Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587348DentalJect CanisterVapocoolshot, IncMLY2025-09-08
00860010587379DentalJect Applicator SetVapocoolshot, IncMLY2025-09-08
00860010587386DentalJect Starter KitVapocoolshot, IncMLY2025-09-08
00860010587331CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncMLY2025-08-01
00860010587324CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
10860010587321CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860006961596CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
00860006961589CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961586CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961524Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
20860006961521Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961527Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961503Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncMLY2023-01-27
20860006961507Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27