FDA.reportPublic FDA data

IVeneer Injectable Matrix System

Primary DI
07290019259145
Brand
IVeneer Injectable Matrix System
Company
IVENEER LTD
Model
Refill Set 2 Left - M/L
Catalog number
IVE2 LeftL
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019259145PrimaryGS10
7290019259145Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019259145072900192591457290019259145

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+972524466628damir@iveneer.com

Regulatory Flags#

DUNS number
600811880
Device count
10
Premarket exempt
true
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
07290019259008IVeneer Injectable Matrix SystemFull Kit 128 unitsIVEF1282024-10-21
07290019259015IVeneer Injectable Matrix SystemIntro Kit 64 size M/LIVEL642024-10-21
07290019259022IVeneer Injectable Matrix SystemIntro Kit 64 size S/MIVES642024-10-21
07290019259039IVeneer Injectable Matrix SystemRefill Set 1 Right - S/MIVE1 RightS2024-10-21
07290019259046IVeneer Injectable Matrix SystemRefill Set 1 Left - S/MIVE1 LeftS2024-10-21
07290019259053IVeneer Injectable Matrix SystemRefill Set 2 Right - S/MIVE2 RightS2024-10-21
07290019259060IVeneer Injectable Matrix SystemRefill Set 2 Left - S/MIVE2 LeftS2024-10-21
07290019259077IVeneer Injectable Matrix SystemRefill Set 3 Right - S/MIVE3 RightS2024-10-21
07290019259084IVeneer Injectable Matrix SystemRefill Set 3 Left - S/MIVE3 LeftS2024-10-21
07290019259091IVeneer Injectable Matrix SystemRefill Set 4 Right - S/MIVE4 RightS2024-10-21
07290019259107IVeneer Injectable Matrix SystemRefill Set 4 Left - S/MIVE4 LeftS2024-10-21
07290019259114IVeneer Injectable Matrix SystemRefill Set 1 Right - M/LIVE1 RightL2024-10-21
07290019259121IVeneer Injectable Matrix SystemRefill Set 1 Left - M/LIVE1 LeftL2024-10-21
07290019259138IVeneer Injectable Matrix SystemRefill Set 2 Right - M/LIVE2 RightL2024-10-21
07290019259152IVeneer Injectable Matrix SystemRefill Set 3 Right - M/LIVE3 RightL2024-10-21
07290019259169IVeneer Injectable Matrix SystemRefill Set 3 Left - M/LIVE3 LeftL2024-10-21
07290019259176IVeneer Injectable Matrix SystemRefill Set 4 Right - M/LIVE4 RighL2024-10-21
07290019259183IVeneer Injectable Matrix SystemRefill Set 4 Left - M/LIVE4 LeftL2024-10-21
07290019259190IVeneer Injectable Matrix SystemStarter Set S/MIVEST12S2024-10-21
07290019259206IVeneer Injectable Matrix SystemFull Kit 64 unitsIVEF642024-10-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10304040193904Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193911Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193928Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193935Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
20686864061155MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10686864060649MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10686864060656MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10810038090495Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090501Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090518Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090525Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090532Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090549Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090556Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090563Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090492Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090508Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090515Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090522Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090539Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
M752ZZ14080STRADIS HEALTHCARESTRADIS MEDICAL, LLCJEP2022-04-29
10686864056482MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864056499MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10686864057151MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864057168MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10304040142803Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12
10304040142827Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12