FDA.reportPublic FDA data

Philips Zoom

Primary DI
00075020044129
Brand
Philips Zoom
Company
Discus Dental, LLC
Model
DIS716/01
Device description
QuickPro Teeth Whitening Procedure Kit
Published
2020-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFNCOTTON, ROLL
EIEDAM, RUBBER
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFNCotton, RollDental1
EIEDam, RubberDental1
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075020044129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020044129000750200441290750200441290075020044129

GMDN Terms#

Term, Definition table
TermDefinition
Gingiva bleaching protectorA non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. It is typically supplied in a disposable syringe and is applied with an applicator along the gingiva leaving the teeth exposed for treatment. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831726109
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08710103611967Philips Zoom! Protective EyewearDIS2038810203303002020-09-20
00075020035011Philips Zoom! WhiteSpeed Whitening LED AcceleratorDIS5588810558015402020-09-23
08710103632085Philips Zoom! WhiteSpeed IsoPrep RetractorDIS5738810573010202020-08-28
08710103632092Philips Zoom! IsoPrep RetractorDIS5748810574010202020-08-28
08710103632061Philips Zoom! Chairside Light-Activated Whitening KitDIS57148810571010202019-06-21
00075020035004Philips Zoom! Chairside Light-Activated Whitening KitDIS5578810557015402016-09-07
00075020043863Philips Relief ACP Oral Care GelDIS2728810272305402016-09-07
00075020065469Philips Zoom! Relief ACP Oral Care GelDIS4558810455015402016-09-07
00075020034991Philips Zoom! Chairside Light-Activated Whitening KitDIS5568810556015402016-09-07
00075020043900Relief ACPDIS445/012016-09-07
00075020089892Relief ACPDIS571/992019-09-24
08710103632122Philips ZoomDIS578/012020-09-23
00075020034311DASHDIS429/012016-09-07
00075020034403Relief ACPDIS455/022016-09-07
00075020034236Philips Sonicare BreathRxDIS442/012020-08-28
00075020034243Philips Sonicare BreathRxDIS442/022020-08-28
00075020048004Philips Sonicare BreathRxDIS251/012020-08-28
00075020048035Philips Sonicare BreathRxDIS357/032020-08-28
00075020048042Philips Sonicare BreathRxDIS357/112020-08-28
00075020048059Philips Sonicare BreathRxDIS359/032020-08-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630392912129HySolateDent4You AGEIE2025-12-18
07630392912136HySolateDent4You AGEIE2025-12-18
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07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07615208516982OptraGate 2IVOCLAR VIVADENT AKTIENGESELLSCHAFTEIF2025-02-21
07615208513660OptraGate 2IVOCLAR VIVADENT AKTIENGESELLSCHAFTEIF2024-11-19
07615208484076OptraGateIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIF2024-09-11
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10686864060380HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060397HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060403HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060410HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060427HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10304040184803Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
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10304040184827Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184858Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184865Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15