FDA.reportPublic FDA data

Cavex

Primary DI
00850079280397
Brand
Cavex
Company
Hexa Dental
Model
BW050
Device description
Bite&White In-Office HP25 Starter Pack
Published
2026-01-22
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
EEGHeat Source For Bleaching Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEGHeat Source For Bleaching TeethDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850079280397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850079280397008500792803978500792803970850079280397

GMDN Terms#

Term, Definition table
TermDefinition
Dental bleaching agentA dental liquid solution, paste or gel [e.g., containing hydrogen peroxide (H2O2)] intended to be used chairside by a healthcare professional to whiten teeth for therapeutic (e.g., restoration of traumatised tooth colour) or cosmetic purposes. It may be supplied as a prefilled applicator or mixing syringe; some types may include a desensitising agent (e.g., potassium nitrate). 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
Donation ID number
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
00872320006440Picasso Pro Diode LaserCAO GROUP, INC.EEG2026-04-10
E241WR0040WR Premium Perfection Kit + LedCavex Holland B.V.EEG2026-03-09
08719327516041WR Premium Perfection Kit + LedCavex Holland B.V.EEG2026-03-09
E241WR0100WR Premium Perfection Kit Led EUCavex Holland B.V.EEG2026-03-09
E241BW0620Cavex Bite&White ExSense BrushpenCavex Holland B.V.EEG2026-03-05
E241BW1600Cavex Bite&White ExSense tubeCavex Holland B.V.EEG2026-03-05
E241BW0070Cavex Bite&White 3 syringes CP16Cavex Holland B.V.EEG2026-03-05
E241BW0080Cavex Bite&White 3 syringes CP22Cavex Holland B.V.EEG2026-03-05
E241BW0310Cavex Bite&White Ready 2 UseCavex Holland B.V.EEG2026-03-05
E241BW0500Cavex Bite&White In-Office 25% Starter Cavex Holland B.V.EEG2026-03-05
E241BW0510Cavex Bite&White In-Office 25% Pen bulkCavex Holland B.V.EEG2026-03-05
E241BW0520Cavex Bite&White In-Office 25% Barrier bulkCavex Holland B.V.EEG2026-03-05
08719327516058Cavex Bite&White ExSense BrushpenCavex Holland B.V.EEG2026-03-05
E241BW0820Cavex Bite&White Aligner Whitening penCavex Holland B.V.EEG2026-03-05
08720299509207Cavex Bite&White ExSense tubeCavex Holland B.V.EEG2026-03-05
00850079280403CavexHexa DentalEEG2026-01-22
00850079280410CavexHexa DentalEEG2026-01-22
00850079280137HEXAHexa DentalEEG2026-01-21
00850079280144HexaHexa DentalEEG2026-01-21
00301260033211Colgate Optic White Professional In Office Whitening KitCOLGATE ORAL PHARMACEUTICALS, INC.EEG2025-11-06
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus LightOrtho Dental Lab LLCEEG2025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLCEEG2025-10-16
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLCEEG2025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLCEEG2025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCEEG2025-09-25
06974624062116PIOONWuhan Pioon Technology Co., Ltd.EEG2025-07-08
06974624062109PIOONWuhan Pioon Technology Co., Ltd.EEG2025-07-07
06972868590013AHVTEFOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTDEEG2025-05-06
06972868590020AHVTEFOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTDEEG2025-05-06
06972868590037AHVTEFOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO.,LTDEEG2025-05-06