Question 1

What types of medical devices does Iveneer Ltd manufacture?

Accepted Answer

Iveneer Ltd specializes in single-use dental matrix bands, specifically designed for veneer procedures. Their primary product, the VeneerNow Injectable Matrix System, is used to create precise margins during dental restorations, particularly in veneer applications. These devices are tailored for dental professionals performing cosmetic or restorative treatments.

Question 2

Where is Iveneer Ltd based, and what is its primary market focus?

Accepted Answer

Iveneer Ltd is based in Israel. Their focus is on dental devices, particularly single-use matrix bands for veneer procedures. The company’s products are intended for use in dental clinics and practices where veneer restorations are performed, ensuring precise and efficient dental restoration processes.

Question 3

Which regulatory registries list Iveneer Ltd’s devices?

Accepted Answer

Iveneer Ltd’s devices are listed in two key regulatory databases: EUDAMED, the European database for medical devices, and the FDA’s Unique Device Identifier (UDI) system, which tracks medical devices in the United States. These listings help ensure transparency and traceability of their products in both markets.

Question 4

How are Iveneer Ltd’s devices classified under medical device regulations?

Accepted Answer

Iveneer Ltd’s devices fall under Class I classification according to the EU Medical Device Regulation (MDR). This classification is typically assigned to low-risk devices, such as single-use dental matrix bands, which pose minimal risk to patients when used as intended. Class I devices often require fewer regulatory controls compared to higher-risk categories.

Device	Model / Reference	Registries	Class	Status
VeneerNow Injectable Matrix System	Premier Refill 5 SM	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 11 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 12 SM	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 12 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 10 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Mini-Kit	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 5 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Sample	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 6 SM	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 9 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 9 SM	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 7 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 11 SM	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 10 SM	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 7 SM	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Starter	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 8 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 6 ML	FDA UDI	Class I	Active
VeneerNow Injectable Matrix System	Premier Refill 8 SM	FDA UDI	Class I	Active
IVeneer injectable matrix system	IVES64	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVEL64	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE3 LeftS	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVES32	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE1 RightS	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE3 RightS	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE2 RightL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE4 LeftS	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVEL32	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE4 LeftL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE1 RightL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE2 LeftL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE3 RightL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE4 RightS	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE4 RighL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVEST12S	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE2 RightS	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE3 LeftL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE1 LeftL	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE1 LeftS	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	VEF128	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVEF64	EUDAMEDFDA UDI	Class I	Active
IVeneer injectable matrix system	IVE2 LeftS	EUDAMEDFDA UDI	Class I	Active

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