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-BPA16	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Wide Fixture Hybrid	S-BWFHR5510	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Mono Fixture	I-MF5514	EUDAMED	Class IIb	Active
Bone Level Mini Short Sinus Abutment	S-BMSSA60	EUDAMED	Class IIb	Active
Impression Coping Octa Abutment Transfer Non-Hex	S-ICOATN	EUDAMEDFDA UDI	Class I	Active
Bone Level Couple Abutment	S-BCA65107	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR4814	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Locator Abutment	S-TLA35	EUDAMEDFDA UDI	Class IIb	Active
i-system i-LiNQ Angled Post	I-SIL300-15(2.5)	EUDAMED	Class IIb	Active
Bone Level Healing Abutment	S-BHA4530	EUDAMEDFDA UDI	Class IIb	Active
Oncological Zygoma Implant	SZ-ONC32.5	EUDAMED	Class IIb	Active
Mono Implant Regular Rough-Large Abutment	MR4112-LAb	EUDAMED	Class IIb	Active
Bone Level Healing Abutment	S-BHA4520	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Narrow Fixture Digital Lab Analog	S-BNFDLA	EUDAMED	Class I	Active
Mono Implant Regular Rough-Large Abutment	MR4908-LAb	EUDAMED	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA2040-15(2)	EUDAMED	Class IIb	Active
Bone Level Mini Locator Abutment	S-BMLA65	EUDAMEDFDA UDI	Class IIb	Active
i-system Locator Abutment Analog	I-SLAA	EUDAMED	Class I	Active
Bone Level Impression Coping Pickup Long	S-BICP55L	EUDAMEDFDA UDI	Class I	Active
Tissue Level Solid Abutment	S-TSA40	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Abutment	I-SILCE40L	EUDAMED	Class IIb	Active
Straight Drill	S-SD2212	EUDAMEDFDA UDI	Class IIa	Active
Pace Ratchet	PK-RATCHET	EUDAMED	Class I	Active
Straight Drill	S-SD4806	EUDAMED	Class IIa	Active
i-system Locator Abutment	I-SLA40(2)	EUDAMED	Class IIb	Active
Bone Level Angled Abutment	S-BAA65252	EUDAMEDFDA UDI	Class IIb	Active
Locator Abutment Driver	S-LAD	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Solid Abutment	S-BMSA3720	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Angled Abutment	I-SILCEN65S-15	EUDAMED	Class IIb	Active
i-system Locator Abutment	I-SLA10(2.5)	EUDAMED	Class IIb	Active
Taping Drill	S-TPD55	EUDAMED	Class IIa	Active
i-system Shouldered Abutment	I-SSA4040(2.5)	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA5540	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Couple Abutment Non-Hex	S-BMCAN3740	EUDAMEDFDA UDI	Class IIb	Active
Pace Premill Multi Unit Scan Body Short	S-PPMUSB48S	EUDAMED	Class I	Active
Tissue Level Healing Abutment Wide	S-THAW30	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR4314	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Lab Analog Large	MLA-LAb	EUDAMED	Class I	Active
Bone Level Mini Multi Abutment	S-BMMUA4825	EUDAMEDFDA UDI	Class IIb	Active
Zygoma Healing Abutment Screw	S-ZHAS7	EUDAMED	Class IIb	Active
Monoimplant Multi Unit Laboratory Analog	MMUALA	EUDAMED	Class I	Active
Bone Level Solid Abutment	S-BSA6540	EUDAMEDFDA UDI	Class IIb	Active
i-system Impression Post	I-SIP(2)	EUDAMED	Class I	Active
Bone Level Healing Abutment	S-BHA5520	EUDAMEDFDA UDI	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA6040(2.5)	EUDAMED	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU3708	EUDAMED	Class IIb	Active
i-system Shouldered Abutment	I-SSA1040(2)	EUDAMED	Class IIb	Active
Bone Level Mini Angled Abutment	S-BMAA37152	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Temporary Abutment Non-Hex	S-BTAN65	EUDAMED	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA2050-15(2.5)	EUDAMED	Class IIb	Active

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