FDA.reportPublic FDA data

Colgate Optic White Professional In Office Whitening Kit

Primary DI
00301260033211
Brand
Colgate Optic White Professional In Office Whitening Kit
Company
COLGATE ORAL PHARMACEUTICALS, INC.
Model
61048281
Device description
LWT3
Published
2025-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10301260033225PackageGS14In Commercial Distribution
00301260033211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030126003322510301260033225
00301260033211003012600332113012600332110301260033211

GMDN Terms#

Term, Definition table
TermDefinition
Tooth-bleaching acceleration unitA heat and/or light source intended to increase the oxidative effect of tooth bleachers (e.g., oxygen peroxide, carbamide peroxide, hydrogen peroxide) during tooth whitening dental procedures. It typically consists of a dedicated electromagnetic energy source (e.g., xenon lamp, LED), which may operate within a specific wavelength range, a laser, or an electric powered heater. The device is typically used during procedures in dental offices.

Contacts#

Phone, Email table
PhoneEmail
1-800-226-5428xx@xx.xx

Regulatory Flags#

DUNS number
968801118
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00035000990754Colgate Optic White Professional Take-Home Whitening Kit610125612023-06-08
00827854000587Colgate Optic White Professional In Office Whitening Kit610201172023-06-08
00301260033228Colgate Optic White Professional Take-Home KitLWT32026-01-26
10301260033218Colgate Optic White Professional Take-Home KitLWT32026-01-26
00035000465214Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14
00035000977786Colgate Profesional Sensitivity Relief Serum TubeUS06793A2021-01-18
00035000465467Colgate Anywhere Anytime Sensitivity Relief SerumUS05495A2018-05-31
00035000466426Colgate Prorelief Sensitivity Relief SerumUS05562A2018-05-31
00035000985835Colgate Total FlossUS07353A2023-08-15
00038341330388Colgate PreviDent Varnish Mint7330962016-09-15
00038341330937Colgate PreviDent Varnish Grape 7330932016-09-15
00038341457955Colgate PreviDent Varnish Caramel SundaeUS05089A2018-05-31
00038341451168Colgate PreviDent Varnish Raspberry - unit doseUS04261A2019-04-08
10035000990751Colgate Optic White Professional Take-Home Whitening Kit610125612023-06-08
00038341330395Colgate PreviDent Varnish Raspberry7330982016-09-15
00035000983749Colgate Profesional Sensitivity Relief Serum TubeUS06793A2021-01-18
10035000970869Colgate Anywhere Anytime Sensitivity Relief SerumUS06364A2019-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00850079280397CavexHexa DentalEEG2026-01-22
00850079280403CavexHexa DentalEEG2026-01-22
00850079280410CavexHexa DentalEEG2026-01-22
00850079280137HEXAHexa DentalEEG2026-01-21
00850079280144HexaHexa DentalEEG2026-01-21
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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
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