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
Multi Unit Impression Coping Transfer-Bridge	S-MUICT-b	EUDAMED	Class I	Active
Bone Level Couple Abutment	S-BCA45507	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Abutment	I-SSA2065(3)	EUDAMED	Class IIb	Active
Tissue Level Fixture Large Lab Analog	S-TFLLA	EUDAMEDFDA UDI	Class I	Active
i-system Shouldered Abutment	I-SSA3040(2.5)	EUDAMED	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU3210	EUDAMED	Class IIb	Active
i-system i-LiNQ Straight Post	I-SIL450(2)	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MSM3512- LAb	EUDAMED	Class IIb	Active
Zygoma Implant	S-ZYG52.5	EUDAMED	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA2050-15(2.5)	EUDAMED	Class IIb	Active
Zygoma Angled Handle	S-ZDIA	EUDAMED	Class I	Active
Neck Drill	S-ND3.7	EUDAMEDFDA UDI	Class IIa	Active
Tissue Level Healing Abutment	S-THA40	EUDAMEDFDA UDI	Class IIb	Active
Bone Level O-Ring Abutment	S-BORA 60	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Mini Rough	MOT3526	EUDAMED	Class IIb	Active
Broken Help Kit Flat Tip	S-BHKFLT	EUDAMED	Class I	Active
Zygoma Healing Abutment	S-ZHA4330	EUDAMED	Class IIb	Active
Mono Implant Regular Rough	MR4110	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Plastic Coping Crown	S-BSAPIC55c	EUDAMEDFDA UDI	Class I	Active
Premill Mini Scan Body	S-PMSB	EUDAMEDFDA UDI	Class I	Active
Mono Implant Smooth -Micro	MSM4017- LAb	EUDAMED	Class IIb	Active
Premill Scan Body Short	S-PSBS	EUDAMED	Class I	Active
Bone Level Angled Abutment	S-BAA55252	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Fixture Hybrid	S-TFHR4314	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN65207	EUDAMED	Class IIb	Active
Bone Level Angled Abutment Non-Hex	S-BAAN65154	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Abutment	I-SSA4050(3)	EUDAMED	Class IIb	Active
Bone Level Narrow Impression Coping Transfer	S-BNICT37	EUDAMED	Class I	Active
Mono Implant Smooth -Micro	MSM3526-LAb	EUDAMED	Class IIb	Active
Tissue Level Impression Coping Pickup	S-TICP	EUDAMEDFDA UDI	Class I	Active
Multi Unit Abutment Plastic Cylinder- Crown	S-MUPICy-c	EUDAMED	Class I	Active
I-Cement Angled Abutment	I-SILCEN40L-15	EUDAMED	Class IIb	Active
i-system Ball Abutment	I-SBA10(2.5)	EUDAMED	Class IIb	Active
Pace Impression Coping Transfer Guide Pin Short	S-PBICTGS	EUDAMED	Class I	Active
i-system Multi Unit Abutment	I-SMUA2050(2)	EUDAMED	Class IIb	Active
Mono Implant Burnout Cap	MBC	EUDAMED	Class I	Active
i-LiNQ Conometric Healing Cap	I-SILCONOHC50	EUDAMED	Class IIb	Active
Pace Impression Coping Pickup Non-Hex Short	S-PBICPN50S	EUDAMED	Class I	Active
Bone Level Mini Angled Abutment Non-Hex	S-BMAAN37152	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR3712	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini O-Ring Abutment	S-BMEBA20	EUDAMED	Class IIb	Active
Pace Impression Coping Pickup Non-Hex Short	S-PBICPN40S	EUDAMED	Class I	Active
Bone Level Mini Short Impression Coping Transfer	S-BMSICT60	EUDAMED	Class I	Active
Bone Level Octa Digital Lab Analog	S-BODLA	EUDAMEDFDA UDI	Class I	Active
Mono Implant Regular Smooth-Large Abutment	MS4029- LAb	EUDAMED	Class IIb	Active
Mono Implant Mini Rough	MR3217	EUDAMED	Class IIb	Active
Tapered Drill	S-TD4808	EUDAMEDFDA UDI	Class IIa	Active
Bone Level Couple Abutment	S-BCA45307	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Impression Coping Transfer Short	S-BMICT37S	EUDAMEDFDA UDI	Class I	Active
i-system Shouldered Angled Abutment	I-SSAA2050-15(2)	EUDAMED	Class IIb	Active

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