FDA.reportPublic FDA data

IvoBase HI / IvoBase Hybrid

Primary DI
07615208297492
Brand
IvoBase HI / IvoBase Hybrid
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
628885AN
Catalog number
628885AN
Device description
IvoBase Hybrid Kit 20 Preference
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DIVO628885AN1PreviousHIBCC0
07615208297492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208297492076152082974927615208297492

GMDN Terms#

Term, Definition table
TermDefinition
Denture base resin kitA collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.

Regulatory Flags#

DUNS number
448015938
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208353723Mixing Tips6459556459552026-08-19
DVIV533297AN1Helioseal533297AN533297AN2016-11-18
DVIV550578AN1Fluor Protector550578AN550578AN2016-12-12
DVIV550579AN1Fluor Protector550579AN550579AN2016-12-12
07615208476804Tetric plus Fill762371WW762371WW2026-07-29
07615208476811Tetric plus Fill762372WW762372WW2026-07-29
07615208476828Tetric plus Fill762373WW762373WW2026-07-29
07615208476835Tetric plus Fill762374WW762374WW2026-07-29
07615208476842Tetric plus Fill762375WW762375WW2026-07-29
07615208477658Tetric plus Fill762386WW762386WW2026-07-29
07615208477665Tetric plus Fill762387WW762387WW2026-07-29
07615208477672Tetric plus Fill762388WW762388WW2026-07-29
07615208477689Tetric plus Fill762389WW762389WW2026-07-29
07615208477696Tetric plus Fill762390WW762390WW2026-07-29
07615208477702Tetric plus Flow762391WW762391WW2026-07-29
07615208477719Tetric plus Flow762392WW762392WW2026-07-29
07615208477726Tetric plus Flow762393WW762393WW2026-07-29
07615208477733Tetric plus Flow762394WW762394WW2026-07-29
07615208477740Tetric plus Flow762395WW762395WW2026-07-29
07615208477757Tetric plus Flow762396WW762396WW2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971437943618UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943625UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943649UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943748UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
00883205041883UltraCemULTRADENT PRODUCTS, INC.EBI2026-08-22
07630813462523XPLEX BaseCandulor AGEBI2026-07-28
00850061175175Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175182Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175199Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
07615208585728Ivotion BaseIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585735IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585766IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585773IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585780IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585797IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585803IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585810IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585827IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585834IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585841IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29