FDA.reportPublic FDA data

IVeneer Injectable Matrix System

Primary DI
7290019259060
Brand
IVeneer Injectable Matrix System
Company
IVENEER LTD
Model
Refill Set 2 Left - S/M
Catalog number
IVE2 LeftS
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
07290019259060PrimaryGS10
7290019259060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019259060072900192590607290019259060

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
600811880
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
07290019259145IVeneer Injectable Matrix SystemRefill Set 2 Left - M/LIVE2 LeftL2024-10-21
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

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