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 Couple Abutment Non-Hex	S-BMCAN37307	EUDAMED	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR3714	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Transfer Large	MIT-LAb	EUDAMED	Class I	Active
Pace Premill Multi Unit Scan Body Long	S-PPMUSB48L	EUDAMED	Class I	Active
Straight Drill	S-SD2214	EUDAMEDFDA UDI	Class IIa	Active
Impression Coping Octa Abutment Pickup Non-Hex	S-ICOAPN	EUDAMEDFDA UDI	Class I	Active
Bone Level Impression Post Guide pin	S-BIPGP	EUDAMEDFDA UDI	Class I	Active
Bone Level Angled Abutment Non-Hex	S-BAAN65254	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Mono Fixture	I-MF4514	EUDAMED	Class IIb	Active
Bone Level Narrow Ti-Base Abutment	S-BNTiA10	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA1050-17(2)	EUDAMED	Class IIb	Active
Bone Level Mini Premill Abutment	S-BMPA10	EUDAMEDFDA UDI	Class IIb	Active
Octa Abutment Plastic Cylinder	S-OAPICy	EUDAMEDFDA UDI	Class I	Active
i-system Shouldered Angled Abutment	I-SSAA4040-15(2.5)	EUDAMED	Class IIb	Active
Multi Unit Abutment Transfer Non Hex	S-MUATN	EUDAMED	Class I	Active
Bone Level Mini Fixture Straight	S-BMFSR3314	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment	S-ZAA43203	EUDAMED	Class IIb	Active
Atrophic Maxillary Zygoma Implant	S-ZAM40	EUDAMED	Class IIb	Active
I-Cement Angled Abutment	I-SILCE50S-25	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA6510	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Rough	MR3706	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Healing Cap	S-BSAHCap65	EUDAMED	Class IIb	Active
i-system i-LiNQ Straight Post	I-SIL450(2.5)	EUDAMED	Class IIb	Active
i-system Ti-Base Abutment	I-STiA2045(2.5)	EUDAMED	Class IIb	Active
i-system Hammer	I-SHMR	EUDAMED	Class I	Active
i-system Multi Unit Angled Abutment	I-SMUA3050-17(3)	EUDAMED	Class IIb	Active
Zygoma Implant Surgical Kit	S-ZSK	EUDAMED	Class I	Active
Zygoma Healing Abutment	S-ZHA4350	EUDAMED	Class IIb	Active
Bone Level Narrow Couple Abutment	S-BNCA35607	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Plastic Coping Crown	S-BSAPIC65c	EUDAMEDFDA UDI	Class I	Active
i-system Multi Unit Angled Abutment	I-SMUA6050-33(2.5)	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA45107	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Abutment	I-SSA2040(2.5)	EUDAMED	Class IIb	Active
Bone Level Angled Abutment	S-BAA45252	EUDAMEDFDA UDI	Class IIb	Active
i-system Implant Surgical Kit	I-SSK	EUDAMED	Class I	Active
I-premill Scan Body	I-PSB(2.5)	EUDAMED	Class I	Active
i-system Shouldered Angled Abutment	I-SSAA4040-25(2.5)	EUDAMED	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA6050-25(2.5)	EUDAMED	Class IIb	Active
i-system Ti-Base Abutment	I-STiA1045(3)	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Plastic Coping Bridge	S-BSAPIC65b	EUDAMEDFDA UDI	Class I	Active
Tissue Level Couple Abutment Wide	S-TCAW10	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment	S-BMUA48291	EUDAMED	Class IIb	Active
Bone Level Mini Premill Abutment	S-BMPA14	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Smooth	MS7014	EUDAMED	Class IIb	Active
O-Ring Lab Analog	S-ORLA	EUDAMEDFDA UDI	Class I	Active
Mono Fixture Wide Smooth- Large Abutment	MS7012-LAb	EUDAMED	Class IIb	Active
Bone Level Aggressive Reamer Drill	S-BARD4.5	EUDAMED	Class IIa	Active
Bone Level Couple Abutment Non-Hex	S-BCAN45507	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS4020	EUDAMED	Class IIb	Active
Bone Level Mini Solid Abutment	S-BMSA3730	EUDAMEDFDA UDI	Class IIb	Active

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