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 Abutment Screw	S-BMUASS	EUDAMED	Class IIb	Active
Bone Level Octa Abutment	S-BOA20	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA2040-25(2.5)	EUDAMED	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN4550	EUDAMEDFDA UDI	Class IIb	Active
Locator Mounting Insert	S-LTMI	EUDAMEDFDA UDI	Class I	Active
Point Drill	S-PD3517	EUDAMED	Class IIa	Active
Locator Processing Spacer	S-LPS	EUDAMEDFDA UDI	Class I	Active
Bone Level Octa Abutment	S-ZMOA4305	EUDAMED	Class IIb	Active
Multi Unit Abutment Plastic Cylinder Non-Hex	S-MUAPICyN	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Couple Abutment Non-Hex	S-BMCAN3750	EUDAMEDFDA UDI	Class IIb	Active
i-system Maxillary Extraction Forceps	I-SFRCL	EUDAMED	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN5540	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Solid Abutment Large Lab Analog	S-TSALLA40	EUDAMEDFDA UDI	Class I	Active
i-system Locator Abutment	I-SLA30(2.5)	EUDAMED	Class IIb	Active
Pace Bone Level Fixture Lab Analog	S-PBFLA	EUDAMED	Class I	Active
O-Ring-B	S-O-RING-B	EUDAMED	Class IIb	Active
Impression Coping Octa Abutment Pickup Guide Pin Long	S-ICOAPG15	EUDAMEDFDA UDI	Class I	Active
Tapered Drill	S-TD3714	EUDAMEDFDA UDI	Class IIa	Active
Mono Fixture Wide Smooth- Large Abutment	MS5520-LAb	EUDAMED	Class IIb	Active
i-system Shouldered Abutment	I-SSA5050(2.5)	EUDAMED	Class IIb	Active
i-system Fixture	I-SF5508(3)	EUDAMED	Class IIb	Active
i-system Plug Remover	I-SPR	EUDAMED	Class I	Active
i-system Multi Unit Abutment	I-SMUA2050(2.5)	EUDAMED	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA4040-15(2.5)	EUDAMED	Class IIb	Active
i-LiNQ Cement Healing Cap	I-SILCEHC50	EUDAMED	Class IIb	Active
Zygoma Implant	S-ZYG40	EUDAMED	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN6510	EUDAMEDFDA UDI	Class IIb	Active
Excellent Ball Contra Angled Driver	S-EBCAD	EUDAMED	Class I	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA6040-15(2.5)	EUDAMED	Class IIb	Active
Mono Implant Mini Smooth-Large Abutment	MS3520- LAb	EUDAMED	Class IIb	Active
i-system Ti-Base Abutment	I-STiA1045(2.5)	EUDAMED	Class IIb	Active
Tissue Level Wide Fixture Hybrid	S-TWFHR5508	EUDAMEDFDA UDI	Class IIb	Active
Bar Matrix Insert Adaptor	S-BMIA	EUDAMEDFDA UDI	Class I	Active
Tapered Drill	S-TD3712	EUDAMEDFDA UDI	Class IIa	Active
Tissue Level Fixture Hybrid	S-TFHR3714	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Connect Welding Cylinder	I-SILCOWCyN	EUDAMED	Class I	Active
i-LiNQ Healing Cap	I-SILHC50L	EUDAMED	Class IIb	Active
i-system Miling Abutment	I-SMIA4050(2)	EUDAMED	Class IIb	Active
Zygoma Implant	S-ZYG50	EUDAMED	Class IIb	Active
Tissue Level Multi Abutment	S-TMA	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN45207	EUDAMED	Class IIb	Active
Bone Level Mini O-Ring Abutment	S-BMEBA40	EUDAMED	Class IIb	Active
Tissue Level Wide Fixture Digital Lab-Analog	S-TWFDLA	EUDAMEDFDA UDI	Class I	Active
Mono Fixture O-Ring Lab Analog	MORLA	EUDAMED	Class I	Active
Straight Drill	S-SD2210	EUDAMEDFDA UDI	Class IIa	Active
Mono Implant Regular Smooth	MS5520	EUDAMED	Class IIb	Active
Zygoma Abutment Screw	S-ZMUASL	EUDAMED	Class IIb	Active
Bone Level Impression Coping Pickup Short	S-BICP55S	EUDAMEDFDA UDI	Class I	Active
i-system i-LiNQ Angled Post	I-SIL150-15(2.5)	EUDAMED	Class IIb	Active
Mono Implant Mini Rough	MR3217-B	EUDAMED	Class IIb	Active

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