FDA.reportPublic FDA data

Philips Zoom

Primary DI
08710103632122
Brand
Philips Zoom
Company
Discus Dental, LLC
Model
DIS578/01
Device description
Zoom! Lamp upgrade Head
Published
2020-09-23
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
IWSShield, eye, radiological
KPYShield, protective, personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEGHeat Source For Bleaching TeethDental1
IWSShield, Eye, RadiologicalRadiology1
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08710103632122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08710103632122087101036321228710103632122

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831726109
Device count
1
Premarket exempt
true
Kit
true
Serial number
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
00075020044129Philips ZoomDIS716/012020-08-28
00075020089892Relief ACPDIS571/992019-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456225097JMUJMU DENTAL, INCEEG2026-09-30
00840456225103JMUJMU DENTAL, INCEEG2026-09-30
00840456225110JMUJMU DENTAL, INCEEG2026-09-30
00816611026663AngioSystems SorbXANGIOSYSTEMS, INCORPORATEDKPY2026-09-29
20748426261936Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261950Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261901Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261925Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00301260033211Colgate Optic White Professional In Office Whitening KitCOLGATE ORAL PHARMACEUTICALS, INC.EEG2025-11-06
10748426143525Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143532Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143504Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143511Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143542Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
00748426143559Medline-MicrotekMicrotek Medical LLCKPY2025-10-10
10748426143099Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143426Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143433Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143457Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
10748426143495Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143061Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143412Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143481Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426144280Medline-MicrotekMicrotek Medical LLCKPY2025-10-08
00748426143078Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
00748426143467DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143471DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
10748426144270DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143443DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00816611026052Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30