FDA.reportPublic FDA data

Vivid KoolWhite

Primary DI
D724A1902001
Brand
Vivid KoolWhite
Company
PEARSON DENTAL SUPPLIES, INC.
Model
A19-0200
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D724A1902001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
082874108
Device count
1
Kit
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D724H6503001Vivid TruEtch 40% H65-03002018-05-09
D724H6503021Vivid TruEtch 40% H65-03022018-05-09
D724H6503041Vivid TruEtch 40% UnisyringeH65-03042018-05-09
D724H6503061Vivid TruEtch 40% Jumbo syringeH65-03062018-05-09
D724H6503081Vivid TruEtch 40% Jumbo syringeH65-03082018-05-09
D724H6503101Vivid TruEtch 10% Kit H65-03102018-05-09
D724Z0603121Vivid Etch 40%z0603122016-06-29
D724Z0603141Vivid Etch 40%Z0603142016-06-29
D724Z0603160Vivid Etch 40%Z0603162016-06-29
D724Z0603180Vivid Etch 40% refillZ0603182016-06-29
D724Z0603200VividEtch 40% Jumbo 60gm RefillZ0603202016-07-07
D724Z0603241Vivid Etch 10%z0603242016-06-29
D724D4407260Vivid TempFill LCD4407462016-06-28
D724S2702701Vivid Root MTA S2702702016-06-30
D724J0800061N'Sure Indicator TapeJ0800062016-07-26
D724J0800081N'Sure Indicator TapeJ0800082016-07-26
D724J0800101N'Sure Indicator TapeJ0800102016-07-26
D724D0104501Vivid Surebond VIID0104502016-06-21
D724D0104521Vivid Surebond VII RefillD0104522016-06-21
D724S2702601Vivid Ceramic PrimeS2702602016-06-30

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Primary DI, Brand, Company table
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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
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E241BW0820Cavex Bite&White Aligner Whitening penCavex Holland B.V.EEG2026-03-05
08720299509207Cavex Bite&White ExSense tubeCavex Holland B.V.EEG2026-03-05
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00850079280144HexaHexa DentalEEG2026-01-21
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00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCEEG2025-09-25
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