FDA.reportPublic FDA data

SR Ivocap High Impact

Primary DI
07615208297447
Brand
SR Ivocap High Impact
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
629288AN
Catalog number
629288AN
Device description
SR Ivocap HI Standard Kit Pref. Implant
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
DIVO629288AN1PreviousHIBCC0
07615208297447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208297447076152082974477615208297447

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.

Sterilization Methods#

Method table
Method

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
07615208458763Bluephase PowerCure667092BE667092BE2026-10-19
07615208477825Tetric plus Flow762403WW762403WW2026-10-19
07615208477832Tetric plus Fill762404WW762404WW2026-10-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942480719550FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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06942480721454FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721461FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722512FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30