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
Octa Abutment Plastic Cylinder Non-Octa	S-OAPICyN	EUDAMEDFDA UDI	Class I	Active
Tissue Level Wide Scan Body	S-TWSB	EUDAMEDFDA UDI	Class I	Active
L-reamer Drill	I-SIRL-55	EUDAMED	Class IIa	Active
Bone Level Mini Solid Abutment Healing Cap	S-BMSAHCap37	EUDAMED	Class IIb	Active
Pace Impressıon Coping Octa Abutment Pick up Non Hex	S-PICOAPN	EUDAMED	Class I	Active
Bone Level Angled Abutment Non-Hex	S-BAAN55152	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Rough -Oring Abutment	MOR3210	EUDAMED	Class IIb	Active
Pace Impression Coping Pickup Non-Hex Long	S-PBICPN50L	EUDAMED	Class I	Active
i-system Fixture	I-SF5506(3)	EUDAMED	Class IIb	Active
Bone Level Solid Abutment	S-BSA5520	EUDAMEDFDA UDI	Class IIb	Active
Pace Octa Abutment Plastic Cylinder Non Octa	S-POAPICYN	EUDAMED	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN65507	EUDAMED	Class IIb	Active
Neck Drill	S-ND3.3	EUDAMEDFDA UDI	Class IIa	Active
Tool Insert Adaptor	S-TFIC	EUDAMEDFDA UDI	Class I	Active
Premill Octa Scan Body	S-POSB	EUDAMEDFDA UDI	Class I	Active
Mono Implant Regular Smooth	MS4017	EUDAMED	Class IIb	Active
Mono Implant Regular Rough-Large Abutment	MR4108-LAb	EUDAMED	Class IIb	Active
Bone Level Multi Abutment	S-BMA55	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN5530	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Rough	MOT4012	EUDAMED	Class IIb	Active
i-system i-LiNQ Angled Post	I-SIL075-15(2.5)	EUDAMED	Class IIb	Active
i-LiNQ Conometric Impression Post	I-SILCONOIP50	EUDAMED	Class I	Active
Locator Extraction Adaptor	S-LEA	EUDAMED	Class I	Active
Bone Level Narrow Abutment Screw	S-BNAS	EUDAMED	Class IIb	Active
Bone Level Mini Healing Abutment	S-BMHA3770	EUDAMEDFDA UDI	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA2050(2.5)	EUDAMED	Class IIb	Active
Straight Drill	S-SD2816	EUDAMED	Class IIa	Active
Excellent Ball Impression Cap	S-EBICAP	EUDAMED	Class I	Active
Bone Level Healing Abutment	S-BHA5510	EUDAMEDFDA UDI	Class IIb	Active
Pace Octa Abutment Plastic Cylinder	S-POAPICY	EUDAMED	Class I	Active
Bone Level Impression Coping Pickup Guide Pin Long	S-BICPGL	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Solid Abutment Lab Analog	S-BMSALA37	EUDAMEDFDA UDI	Class I	Active
i-system Multi Unit Angled Abutment	I-SMUA6050-17(2)	EUDAMED	Class IIb	Active
Mono Implant Regular Rough	MOT4026	EUDAMED	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA4050-25(2)	EUDAMED	Class IIb	Active
i-LiNQ Conometric Welding Antenna Cap	I-SILCONOWAC	EUDAMED	Class I	Active
Bone Level Mini Impression Coping Transfer Non-Hex Short	S-BMICTN37S	EUDAMEDFDA UDI	Class I	Active
i-LiNQ connect Abutments	I-SILCONL-17	EUDAMED	Class IIb	Active
Bone Level Mini Impression Coping Transfer Non-Hex Long	S-BMICTN37L	EUDAMEDFDA UDI	Class I	Active
Tissue Level Solid Abutment Large	S-TSAL70	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Locator Abutment	S-BLA45	EUDAMEDFDA UDI	Class IIb	Active
i-system Fixture	I-SF5504(3)	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Lab Analog	S-BSALA65	EUDAMEDFDA UDI	Class I	Active
Tissue Level Impression Coping Transfer Non-Octa	S-TICTN	EUDAMEDFDA UDI	Class I	Active
i-system Multi Unit Abutment	I-SMUA6050(2.5)	EUDAMED	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN55207	EUDAMED	Class IIb	Active
i-system i-LiNQ Straight Post	I-SIL375(2)	EUDAMED	Class IIb	Active
Taping Drill	S-TPD43	EUDAMED	Class IIa	Active
i-system Fixture	I-SF4510(3)	EUDAMED	Class IIb	Active
Bone Level Mini Short Impression Pickup Transfer	S-BMSICP60	EUDAMED	Class I	Active

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