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
Bone Level Mini Multi Abutment	S-BMMUA4845	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Smooth -Micro	MSM4020-LAb	EUDAMED	Class IIb	Active
Bone Level Narrow Hybrid Fixture	S-BNFHR2910	EUDAMED	Class IIb	Active
i-system Multi Unit Abutment	I-SMUA1050(2)	EUDAMED	Class IIb	Active
Premill Narrow Scan Body	S-PNSB	EUDAMED	Class I	Active
i-system Fixture	I-SF5008(3)	EUDAMED	Class IIb	Active
Bone Level Narrow Closing Screw	S-BNCLS	EUDAMED	Class IIb	Active
Tissue Level Temporary Abutment	S-TTA10	EUDAMED	Class IIb	Active
Bone Level Multi Abutment	S-BMUA4825	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Mini Rough	MOT3529	EUDAMED	Class IIb	Active
Tissue Level Impression Coping Pickup Wide Non-Octa	S-TICPWN	EUDAMED	Class I	Active
Lance Drill	S-LC4020	EUDAMED	Class IIa	Active
Multi Unit Abutment Carrier	S-MUAC	EUDAMED	Class I	Active
Point Drill	S-PD2017	EUDAMED	Class IIa	Active
Tissue Level Scan Body	S-TSB	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Healing Abutment	S-BMHA3750	EUDAMEDFDA UDI	Class IIb	Active
Straight Drill	S-SD4805	EUDAMED	Class IIa	Active
Bone Level O-Ring Abutment	S-BORA05	EUDAMEDFDA UDI	Class IIb	Active
Multi Unit Impression Coping Pick Up - Crown	S-MUICP-c	EUDAMED	Class I	Active
i-system Healing Abutment	I-SHA1050(2.5)	EUDAMED	Class IIb	Active
Tissue Level Wide Premill Abutment	S-TWPA10	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Mini Smooth-Large Abutment	MS3523- LAb	EUDAMED	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR4312	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Narrow Fixture Lab Analog	S-BNFLA	EUDAMED	Class I	Active
O-Ring Retainer/open	S-ORRo-p	EUDAMED	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS5514-LAb	EUDAMED	Class IIb	Active
Lindeman Drill	S-LD4020	EUDAMED	Class IIa	Active
i-system Ball Abutment	I-SBA50(2)	EUDAMED	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS7008-LAb	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS5523	EUDAMED	Class IIb	Active
i-system Fixture	I-SF3008(2)	EUDAMED	Class IIb	Active
Bone Level Healing Abutment	S-BHA5530	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ connect Abutments	I-SILCOS	EUDAMED	Class IIb	Active
Pace Impressıon Coping Octa Abutment Pick up	S-PICOAP	EUDAMED	Class I	Active
Bone Level Mini Healing Abutment	S-BMHA3735	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Digital Lab Analog	I-SIDLA	EUDAMED	Class I	Active
Straight Drill	S-SD4304	EUDAMED	Class IIa	Active
i-LiNQ Mono Fixture	I-MF4508	EUDAMED	Class IIb	Active
Bone Level Mini Angled Abutment	S-BMAA37154	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Rough	MR3715-B	EUDAMED	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN55107	EUDAMED	Class IIb	Active
Bone Level Healing Abutment	S-BHA4540	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Impression Coping Transfer Guide Pin Short	S-BMICTGS	EUDAMEDFDA UDI	Class I	Active
Premill Scan Body	S-PSB	EUDAMEDFDA UDI	Class I	Active
Tissue Level Premill Abutment	S-TPA10	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Conometric Abutment	I-SILCONO65R	EUDAMED	Class IIb	Active
Pace Octa Abutment Lab Analog	S-POALA	EUDAMED	Class I	Active
Mono Fixture Wide Smooth- Large Abutment	MS5508-LAb	EUDAMED	Class IIb	Active
Mono Implant Mini Rough	MR3012	EUDAMED	Class IIb	Active
Tissue Level Fixture Hybrid	S-TFHR4812	EUDAMEDFDA UDI	Class IIb	Active

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