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 Premill Abutment	S-BPA10	EUDAMEDFDA UDI	Class IIb	Active
i-system i-LiNQ Angled Post	I-SIL375-15(2.5)	EUDAMED	Class IIb	Active
Bone Level Angled Abutment	S-ZMUA43175	EUDAMED	Class IIb	Active
Tissue Level O-Ring Abutment	S-TEBA20	EUDAMED	Class IIb	Active
Tissue Level Temporary Abutment	S-TTA20	EUDAMED	Class IIb	Active
Bone Level Temporary Abutment	S-BTA65	EUDAMED	Class IIb	Active
Mono Implant Mini Rough	MR3015	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA2050-17(2)	EUDAMED	Class IIb	Active
Pterygoid Implant	S-PTRY24	EUDAMED	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR4310	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ connect Abutments	I-SILCOR	EUDAMED	Class IIb	Active
I-Cement Angled Abutment	I-SILCEN65S-25	EUDAMED	Class IIb	Active
Zygoma Abutment Screw	S-ZAS	EUDAMED	Class IIb	Active
Bone Level Mini Angled Abutment Non-Hex	S-BMAAN37151	EUDAMEDFDA UDI	Class IIb	Active
Atrophic Maxillary Zygoma Implant	S-ZAM47.5	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA65207	EUDAMEDFDA UDI	Class IIb	Active
Implantswiss Dental Implant Prosthetic Kit	S-BTPK	EUDAMEDFDA UDI	Class I	Active
Twist Drill	S-TWD29100	EUDAMED	Class IIa	Active
i-system Fixture	I-SF4508(3)	EUDAMED	Class IIb	Active
Tissue Level O-Ring Abutment	S-TEBA05	EUDAMED	Class IIb	Active
Zygoma Implant	S-ZYG57.5	EUDAMED	Class IIb	Active
i-LiNQ Ball Abutment	I-SILBAS	EUDAMED	Class IIb	Active
Bone Level Mini Couple Abutment	S-BMCA3720	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA55407	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment	S-BMUA48353	EUDAMED	Class IIb	Active
i-LiNQ Conometric Premill Scan Body Long	I-SILCONOPSBL	EUDAMED	Class I	Active
Point Drill	S-PD	EUDAMEDFDA UDI	Class IIa	Active
Tissue Level Wide Scan Body Short	S-TWSBS	EUDAMED	Class I	Active
Bone Level Solid Abutment Impression Cap	S-BSAICap65	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Couple Abutment	S-BMCA37107	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Locator Abutment Analog	I-SILLAA	EUDAMED	Class I	Active
Hex Ratchet Driver Extra Short	S-12HDRXS	EUDAMEDFDA UDI	Class I	Active
i-LiNQ Lab Analog	I-SILA	EUDAMED	Class I	Active
Bone Level Mini Multi Abutment	S-BMMUA4835	EUDAMEDFDA UDI	Class IIb	Active
Ti-Base Scan Body Short	S-TiSBS	EUDAMED	Class I	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA4050-15(2)	EUDAMED	Class IIb	Active
Bone Level Mini O-Ring Abutment	S-BMEBA05	EUDAMED	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA1050(2)	EUDAMED	Class IIb	Active
Tissue Level Wide Short Fixture Straight	S-TWFSR5505	EUDAMED	Class IIb	Active
i-system Fixture	I-SF3506(2)	EUDAMED	Class IIb	Active
i-system Healing Abutment	I-SHA3050(3)	EUDAMED	Class IIb	Active
i-system Sinus Abutment	I-SSINA6075(3)	EUDAMED	Class IIb	Active
Tapered Drill	S-TD5510	EUDAMEDFDA UDI	Class IIa	Active
Pace Abutment Lab Analog	S-PBMUALA48	EUDAMED	Class I	Active
I-Cement Abutment Digital Lab Analog	I-SILCEADLA	EUDAMED	Class I	Active
i-system Healing Abutment	i-system Healing Abutment	EUDAMED	Class IIb	Active
Mono Implant Mini Smooth	MS2717	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA3050-45(3)	EUDAMED	Class IIb	Active
Bone Level Angled Abutment Non-Hex	S-BAAN65152	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Smooth	MS4023	EUDAMED	Class IIb	Active

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