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
Straight Drill	S-SD2812	EUDAMEDFDA UDI	Class IIa	Active
Bone Level Mini Fixture Lab Analog	S-BMFLA	EUDAMEDFDA UDI	Class I	Active
Zygoma Implant	S-ZYG42.5	EUDAMED	Class IIb	Active
Tissue Level Fixture Hybrid	S-TFHR3708	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment	S-BMUA48172	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Abutment	I-SSA1050(3)	EUDAMED	Class IIb	Active
Bone Level Narrow Hybrid Fixture	S-BNFHR2912	EUDAMED	Class IIb	Active
Octa Abutment Driver Long	S-OADL	EUDAMEDFDA UDI	Class I	Active
Bone Level Fixture Hybrid	S-BFHR4808	EUDAMEDFDA UDI	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA6050-17(3)	EUDAMED	Class IIb	Active
i-system Ti-Base Abutment	I-STiA2045(2)	EUDAMED	Class IIb	Active
Bone Level Mini Fixture Straight	S-BMFSR3310	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Locator Abutment	S-BLA55	EUDAMEDFDA UDI	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS5517-LAb	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS5514	EUDAMED	Class IIb	Active
i-LiNQ Connect Impression Post Closed Tray	I-SILCOIP-1	EUDAMED	Class I	Active
Tissue Level Locator Abutment	S-TLA25	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Rough	MOT4014	EUDAMED	Class IIb	Active
Bone Level Mini Healing Abutment	S-BMHA8020	EUDAMED	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN65107	EUDAMED	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR4812	EUDAMEDFDA UDI	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA2040-25(2.5)	EUDAMED	Class IIb	Active
Pace Impression Coping Pickup Short	S-PBICP50S	EUDAMED	Class I	Active
Mono Implant Mini Smooth	MS3517	EUDAMED	Class IIb	Active
Bone Level Impression Coping Pickup Non-Hex Long	S-BICPN55L	EUDAMEDFDA UDI	Class I	Active
Mono Implant Rough -Oring Abutment	MOR4110	EUDAMED	Class IIb	Active
i-system Miling Abutment	I-SMIA5050(2)	EUDAMED	Class IIb	Active
Mono Implant Mini Smooth	MS2710	EUDAMED	Class IIb	Active
i-system Locator Abutment	I-SLA10(2)	EUDAMED	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA1050(3)	EUDAMED	Class IIb	Active
Bone Level Mini Couple Abutment	S-BMCA5020	EUDAMED	Class IIb	Active
I-LiNQ Impression Post	I-SILIP50	EUDAMED	Class I	Active
i-system Miling Abutment	I-SMIA1050(2)	EUDAMED	Class IIb	Active
Locator Impression Cap	S-LICAP	EUDAMEDFDA UDI	Class I	Active
Tissue Level Premill Abutment	S-TPA16	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Multi Unit Abutment Lab Analog	S-BMUALA40	EUDAMEDFDA UDI	Class I	Active
Tissue Level Impression Coping Pickup Guide Pin Short	S-TICPGS	EUDAMEDFDA UDI	Class I	Active
i-system Ring Abutment Analog	I-SRAA	EUDAMED	Class I	Active
I-Cement Abutment Analog	I-SILCEA40	EUDAMED	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN6520	EUDAMEDFDA UDI	Class IIb	Active
Oring Abutment Driver Short	S-ORADS	EUDAMEDFDA UDI	Class I	Active
Bone Level Solid Abutment	S-BSA6530	EUDAMEDFDA UDI	Class IIb	Active
Oncological Zygoma Implant	SZ-ONC25	EUDAMED	Class IIb	Active
i-system Fixture	I-SF4008(2.5)	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA65307	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN55307	EUDAMED	Class IIb	Active
i-system i-LiNQ Straight Post	I-SIL075(2)	EUDAMED	Class IIb	Active
i-LiNQ Impression Coping	I-SILIC65	EUDAMED	Class I	Active
Lindeman Drill	S-LD3020	EUDAMED	Class IIa	Active
Bone Level Multi Abutment	S-BMUA4805	EUDAMEDFDA UDI	Class IIb	Active

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