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
Straight Drill	S-SD5506	EUDAMED	Class IIa	Active
Tissue Level Locator Abutment	S-TLA45	EUDAMEDFDA UDI	Class IIb	Active
Tapered Drill	S-TD5512	EUDAMEDFDA UDI	Class IIa	Active
Bone Level Healing Abutment	S-BHA6510	EUDAMEDFDA UDI	Class IIb	Active
Atrophic Maxillary Zygoma Implant	S-ZAM35	EUDAMED	Class IIb	Active
Bone Level Angled Abutment Non-Hex	S-BAAN45252	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Closing Screw Wide	S-TCISW	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Healing Abutment	S-BMHA3725	EUDAMEDFDA UDI	Class IIb	Active
Tapered Drill	S-TD4312	EUDAMEDFDA UDI	Class IIa	Active
Straight Drill	S-SD2808	EUDAMEDFDA UDI	Class IIa	Active
i-LiNQ Mono Fixture	I-MF3508	EUDAMED	Class IIb	Active
Digital Lab Analog Screw	S-DLAS	EUDAMED	Class I	Active
i-system Shouldered Angled Abutment	I-SSAA2050-25(2.5)	EUDAMED	Class IIb	Active
Tissue Level Solid Abutment Plastic Coping Bridge	S-TSAPICb	EUDAMEDFDA UDI	Class I	Active
Zygoma Implant	S-ZYG45	EUDAMED	Class IIb	Active
Tissue Level Couple Abutment	S-TCA40	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA6530	EUDAMEDFDA UDI	Class IIb	Active
i-system Ti-Base Abutment	I-STiA3045(2)	EUDAMED	Class IIb	Active
Mono Implant Mini Smooth	MS2726	EUDAMED	Class IIb	Active
Tissue Level Locator Abutment	Tissue Level Locator Abutment	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Abutment Screw	S-BMUAS	EUDAMEDFDA UDI	Class IIb	Active
Tapered Drill	S-TD3708	EUDAMEDFDA UDI	Class IIa	Active
Tissue Level Couple Abutment Non-Octa	S-TCAN20	EUDAMEDFDA UDI	Class IIb	Active
i-system Healing Abutment	I-SHA6040(2.5)	EUDAMED	Class IIb	Active
Pace Impression Coping Transfer Short	S-PBICT50S	EUDAMED	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN65307	EUDAMED	Class IIb	Active
I-Cement Angled Abutment	I-SILCE50L-25	EUDAMED	Class IIb	Active
Bone Level Mini Octa Abutment	S-BMOA30	EUDAMEDFDA UDI	Class IIb	Active
Pace Multi Unit Abutment Transfer Non Hex	S-PMUATN48	EUDAMED	Class I	Active
i-system Fixture	I-SF5505(3)	EUDAMED	Class IIb	Active
i-system Healing Abutment	I-SHA1050(3)	EUDAMED	Class IIb	Active
Tissue Level Multi Abutment Non-Octa	S-TMAN	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Solid Abutment Positioning Cylinder	S-TSAPoCy	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Octa Abutment	S-BMOA20	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN4540	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Solid Abutment Plastic Coping Crown	S-BSAPIC45c	EUDAMEDFDA UDI	Class I	Active
Bone Level O-Ring Abutment	S-BEBA30	EUDAMED	Class IIb	Active
Bone Taping Drill	S-BT3210	EUDAMED	Class IIa	Active
Bone Level Angled Abutment Non-Hex	S-BAAN45152	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU4110	EUDAMED	Class IIb	Active
Bone Level Impression Coping Pickup Long	S-BICP45L	EUDAMEDFDA UDI	Class I	Active
Bone Level Multi Abutment	S-BMA45	EUDAMEDFDA UDI	Class IIb	Active
Zygoma Drill Guard Short	S-ZDGS	EUDAMED	Class I	Active
Zygoma Handle	S-ZHDL	EUDAMED	Class I	Active
Bone Level Couple Abutment	S-BCA4550	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Multi Abutment	S-BMMUA4815	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Solid Abutment Large	S-TSAL55	EUDAMEDFDA UDI	Class IIb	Active
Twist Drill	S-TWD35100	EUDAMED	Class IIa	Active
Mono Fixture Wide Smooth- Large Abutment	MS9010-LAb	EUDAMED	Class IIb	Active
I-Cement Abutment Sealing Plug	I-SILCESPlg	EUDAMED	Class I	Active

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