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
i-LiNQ Scan Body	I-SILPSB	EUDAMED	Class I	Active
i-system Shouldered Abutment	I-SSA4040(2)	EUDAMED	Class IIb	Active
Taping Drill	S-TPD48	EUDAMED	Class IIa	Active
Mono Implant Smooth -Micro	MSM4026- LAb	EUDAMED	Class IIb	Active
Bone Level Mini Octa Abutment	S-BMOA50	EUDAMEDFDA UDI	Class IIb	Active
Pace Impression Coping Pickup Guide Pin Long	S-PBICPGL	EUDAMED	Class I	Active
Mono Implant Mini Smooth	MS2714	EUDAMED	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA2040-15(2)	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth-Large Abutment	MS4032- LAb	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS9012	EUDAMED	Class IIb	Active
Bone Level Octa Abutment	S-BOA50	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Impression Coping Pickup Short	S-BMICP37S	EUDAMEDFDA UDI	Class I	Active
Mono Implant Rough -Multi Unit Abutment	MMU3212	EUDAMED	Class IIb	Active
Bone Level Impression Coping Pickup Long	S-BICP65L	EUDAMEDFDA UDI	Class I	Active
i-system Shouldered Angled Abutment	I-SSAA4050-15(3)	EUDAMED	Class IIb	Active
i-LiNQ Connect Impression Post Guide Pin	I-SILCOIPGpin	EUDAMED	Class I	Active
Bone Level Mini Impression Coping Pickup Non-Hex Long	S-BMICPN37L	EUDAMEDFDA UDI	Class I	Active
i-LiNQ Mono Fixture	I-MF2712	EUDAMED	Class IIb	Active
Zygoma Healing Abutment Screw	S-ZHAS5	EUDAMED	Class IIb	Active
Bone Level Solid Abutment	S-BSA4530	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Solid Abutment Large Lab Analog	S-TSALLA70	EUDAMEDFDA UDI	Class I	Active
Bone Level Angled Abutment Non-Hex	S-BAAN45254	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Impression Components Large	MIC-LAb	EUDAMED	Class I	Active
Taping Drill	S-TP4304	EUDAMED	Class IIa	Active
Impression Coping Octa Abutment Transfer Guide Pin Short	S-ICOATG10	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Locator Abutment	S-BMLA25	EUDAMEDFDA UDI	Class IIb	Active
O-Ring Retainer/closed	S-ORRc	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Fixture Straight	S-BMFSR3308	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Rough -Oring Abutment	MOR3010	EUDAMED	Class IIb	Active
Bone Level Impression Coping Pickup Non-Hex Short	S-BICPN45S	EUDAMEDFDA UDI	Class I	Active
Tapered Aggressive Drill	S-TAD4312	EUDAMED	Class IIa	Active
Bone Level Solid Abutment Plastic Coping Bridge	S-BSAPIC55b	EUDAMEDFDA UDI	Class I	Active
Tissue Level Couple Abutment	S-TCA10	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Impression Coping Transfer Guide Pin Long	S-BMICTGL	EUDAMEDFDA UDI	Class I	Active
Bone Level Narrow Couple Abutment	S-BNCA35207	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS4026	EUDAMED	Class IIb	Active
I-Cement Angled Abutment	I-SILCE65S-15	EUDAMED	Class IIb	Active
Mono Implant Regular Rough-Large Abutment	MR4912-LAb	EUDAMED	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA4065-25(3)	EUDAMED	Class IIb	Active
i-system Sinus Abutment	I-SSINA5065(3)	EUDAMED	Class IIb	Active
Oring Abutment Driver Long	S-ORADL	EUDAMEDFDA UDI	Class I	Active
Tissue Level Fixture Hybrid	S-TFHR4810	EUDAMEDFDA UDI	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS9012-LAb	EUDAMED	Class IIb	Active
Tissue Level Solid Abutment Lab Analog	S-TSALA70	EUDAMEDFDA UDI	Class I	Active
Bone Level Fixture Hybrid	S-BFHR4810	EUDAMEDFDA UDI	Class IIb	Active
i-system Locator Abutment	I-SLA50(2.5)	EUDAMED	Class IIb	Active
Bone Level Mini Octa Abutment	S-BMOA10	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Closing Screw	S-BMCIS	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Angled Abutment	I-SILCEN40R-15	EUDAMED	Class IIb	Active
Mono Implant Regular Rough	MR3717	EUDAMED	Class IIb	Active

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