Question 1

What types of medical devices does Novodent SA manufacture?

Accepted Answer

Novodent SA specializes in dental medical devices, including reusable surgical screwdrivers for dental procedures, preformed permanent suprastructures for dental implants, and dental implant abutment analogs designed for laboratory use. Their portfolio also covers drill bit extensions for precision drilling and dental implant suprastructure kits. Examples include the Bone Level Multi Unit Angled Abutment, Mono Implant Regular Smooth-Large Abutment, and the Implantswiss line of implant systems.

Question 2

Where is Novodent SA based, and what is its primary focus?

Accepted Answer

Novodent SA is based in Switzerland. The company focuses on developing and manufacturing dental implant-related devices, such as abutments, suprastructures, and tools used in dental implantology. Their offerings cater to both clinical and laboratory settings, ensuring precision and compatibility with implant systems.

Question 3

Which regulatory registries list Novodent SA’s devices?

Accepted Answer

Novodent SA’s devices are listed in the EUDAMED database under the EU Medical Device Regulations framework. Additionally, their products appear in the FDA’s 510(k) premarket notification and UDI (Unique Device Identification) registries in the United States, reflecting their compliance with both EU and US regulatory requirements.

Question 4

How are Novodent SA’s devices classified under medical device regulations?

Accepted Answer

Novodent SA’s devices fall under various classifications within the EU Medical Device Regulations, including Class I (low-risk devices), Class IIa (moderate-risk devices with special controls), and Class IIb (higher-risk devices requiring stringent scrutiny). The classification depends on factors like the device’s intended use, potential risks, and interaction with patients, ensuring appropriate regulatory oversight.

Question 5

What distinguishes Novodent SA’s dental implant devices from others in the market?

Accepted Answer

Novodent SA’s devices are designed with a focus on precision and compatibility within dental implant systems, such as their preformed suprastructures and abutment analogs. For example, their Bone Level Multi Unit Angled Abutment and Mono Implant Regular Smooth-Large Abutment are tailored for specific clinical needs, while their reusable surgical screwdrivers and drill bit extensions enhance procedural efficiency. The company’s offerings span both clinical and laboratory use, addressing multiple stages of dental implantology.

Device	Model / Reference	Registries	Class	Status
Zygoma Implant	S-ZYG47.5	EUDAMED	Class IIb	Active
i-system Healing Abutment	I-SHA6050(2)	EUDAMED	Class IIb	Active
i-system Fixture	I-SF4005(2.5)	EUDAMED	Class IIb	Active
Mono Implant Mini Rough	MR3208	EUDAMED	Class IIb	Active
i-LiNQ Mono Fixture	I-MF5510	EUDAMED	Class IIb	Active
Bone Level O-Ring Abutment	S-BORA30	EUDAMEDFDA UDI	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS7014-LAb	EUDAMED	Class IIb	Active
Bone Level Solid Abutment	S-BSA5550	EUDAMEDFDA UDI	Class IIb	Active
Solid Abutment Driver	S-SAD	EUDAMEDFDA UDI	Class I	Active
I-Cement Impression Post Pin	I-SILCEIPpin	EUDAMED	Class I	Active
Bone Level Mini Couple Abutment	S-BMCA3730	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Solid Abutment	S-BMSA3740	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Lab Analog	MLA	EUDAMED	Class I	Active
O-Ring-R	S-O-RING-R	EUDAMED	Class IIb	Active
Tissue Level Short Fixture Straight	S-TFSR4306	EUDAMED	Class IIb	Active
Pilot Drill	S-PLD	EUDAMEDFDA UDI	Class IIa	Active
Bone Level Mini Angled Abutment Non-Hex	S-BMAAN37154	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Multi Abutment	S-BMUA4815	EUDAMEDFDA UDI	Class IIb	Active
Ti-Base Scan Body	S-TiSB	EUDAMED	Class I	Active
Tapered Drill	S-TD3710	EUDAMEDFDA UDI	Class IIa	Active
Bone Level Wide Fixture Hybrid	S-BWFHR5508	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Angled Abutment	I-SILCEN40S-15	EUDAMED	Class IIb	Active
Tapered Drill	S-TD4310	EUDAMEDFDA UDI	Class IIa	Active
Tissue Level Fixture Hybrid	S-TFHR4312	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Couple Abutment	S-BMCA37307	EUDAMEDFDA UDI	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA6050-33(2)	EUDAMED	Class IIb	Active
i-system i-LiNQ Angled Post	I-SIL300-15(2)	EUDAMED	Class IIb	Active
i-system Fixture	I-SF4510(2.5)	EUDAMED	Class IIb	Active
Bone Level Angled Abutment	S-BAA65154	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Angled Abutment	I-SILCE65L-25	EUDAMED	Class IIb	Active
Mono Implant Smooth -Micro	MSM3514- LAb	EUDAMED	Class IIb	Active
I-Connect Abutment Analog	I-SILCOA	EUDAMED	Class I	Active
Bone Level Multi Abutment	S-BMUA4845	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level O-Ring Abutment	S-TORA05	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA65507	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Impression Coping Pickup Non-Hex Short	S-BICPN55S	EUDAMEDFDA UDI	Class I	Active
Bone Level Solid Abutment	S-BSA5510	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Locator Abutment	S-BLA25	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Fixture Digital Lab Analog	S-BMFDLA	EUDAMEDFDA UDI	Class I	Active
Bone Level Locator Lab Analog	S-BLLA	EUDAMEDFDA UDI	Class I	Active
Bone Level Angled Abutment	S-BAA55154	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Angled Abutment	I-SILCEN65R-15	EUDAMED	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA4050-25(2.5)	EUDAMED	Class IIb	Active
i-LiNQ Mono Fixture	I-MF5512	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA1050-33(3)	EUDAMED	Class IIb	Active
Bone Level Mini O-Ring Abutment	S-BMORA05	EUDAMEDFDA UDI	Class IIb	Active
i-system Healing Abutment	I-SHA5050(3)	EUDAMED	Class IIb	Active
I-Cement Abutment	I-SILCE65S	EUDAMED	Class IIb	Active
Tissue Level Healing Abutment Wide	S-THAW40	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Conometric Healing Cap	I-SILCONOHC65	EUDAMED	Class IIb	Active

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