FDA.reportPublic FDA data

Bluephase G2

Primary DI
DVIV607920BU1
Brand
Bluephase G2
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
607920BU
Catalog number
607920BU
Device description
Bluephase 100-240V (G2)
Published
2021-01-27
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBZActivator, Ultraviolet, For PolymerizationDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DVIV607920BU1PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
448015938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
DVIV687778WW0Adhese Universal DC687778WW687778WW2026-03-17
DVIV687779WW0Adhese Universal DC687779WW687779WW2026-03-17
07615208482416OptraSculpt759593AN759593AN2026-03-13
07615208482423OptraSculpt759595AN759595AN2026-03-13
07615208590500OptraSculpt760474AN760474AN2026-03-13
07615208590678OptraSculpt760475AN760475AN2026-03-13
07615208590494OptraSculpt760476AN760476AN2026-03-13
07615208482768OptraSculpt760477AN760477AN2026-03-13
07615208315349Modeling Liquids Ceramic7015887015882026-03-05
07615208338027Modeling Liquids Ceramic6733746733742026-03-05
07615208338058Modeling Liquids Ceramic6733716733712026-03-05
07615208374292Modeling Liquids Ceramic6053666053662026-03-05
07615208488401OptraSculpt683100AN683100AN2026-01-15
07615208445596OptraSculpt683069AN683069AN2026-01-15
07615208445602OptraSculpt683068AN683068AN2026-01-15
07615208486254OptraSculpt639793AN639793AN2026-01-15
07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506191Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
00810126506207Luminary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEBZ2026-03-05
J014660164550Starlight proKulzer GmbHEBZ2026-01-28
J014660573650Starlight proKulzer GmbHEBZ2026-01-28
J014660968300Starlight proKulzer GmbHEBZ2026-01-28
J014660969290Starlight proKulzer GmbHEBZ2026-01-28
J014660971690Starlight proKulzer GmbHEBZ2026-01-28
J014660971700Starlight proKulzer GmbHEBZ2026-01-28
00883205044372Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044389Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044396Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044402Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044419Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
00883205044426Valo XULTRADENT PRODUCTS, INC.EBZ2025-12-04
D0029444001SmartLite® Pro Modular LED Curing LightDENTSPLY INTERNATIONAL INC.EBZ2025-09-09
00883205035561Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-21
00883205041906VALOULTRADENT PRODUCTS, INC.EBZ2025-08-21
00883205032997VALOULTRADENT PRODUCTS, INC.EBZ2025-08-20
00883205042873Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042880Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042897Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042903Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042910Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042927Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205042934Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043269Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043276Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043283Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043290Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14
00883205043306Valo XULTRADENT PRODUCTS, INC.EBZ2025-08-14