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 Mini Multi Abutment	S-BMMUA4805	EUDAMEDFDA UDI	Class IIb	Active
i-reamer Drill	I-SIR-60	EUDAMED	Class IIa	Active
Bone Level Multi Abutment NON-HEX	S-BMAN45	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Healing Abutment	S-BHA4510	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Healing Abutment	S-THA35	EUDAMED	Class IIb	Active
L-reamer Drill	I-SIRL-30	EUDAMED	Class IIa	Active
Monoimplant Multi Unit Transfer	MMUAT	EUDAMED	Class I	Active
Ratchet	S-T-RATCHET	EUDAMEDFDA UDI	Class I	Active
Mono Implant Regular Rough	MR3710	EUDAMED	Class IIb	Active
Pace Bone Level Octa Digital Lab Analog	S-PBODLA	EUDAMED	Class I	Active
i-system Abutment Impression Coping	I-SAICP(2)	EUDAMED	Class I	Active
Mono Implant Mini Rough	MR3212	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA55507	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN55407	EUDAMED	Class IIb	Active
Zygoma Implant	S-ZYG37.5	EUDAMED	Class IIb	Active
Bone Level Locator Abutment	S-BLA35	EUDAMEDFDA UDI	Class IIb	Active
Octa Abutment Screw	S-MUAHS	EUDAMED	Class IIb	Active
Taping Drill	S-TP5504	EUDAMED	Class IIa	Active
Tissue Level Couple Abutment Wide	S-TCAW30	EUDAMEDFDA UDI	Class IIb	Active
i-system Scissors	I-SCS	EUDAMED	Class I	Active
I-Cement Angled Abutment	I-SILCE40S-15	EUDAMED	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR3710	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Smooth	MS4523	EUDAMED	Class IIb	Active
i-system i-LiNQ Angled Post	I-SIL225-15(3)	EUDAMED	Class IIb	Active
Bone Level Solid Abutment	S-BSA4510	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA6050-15(2)	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS4035	EUDAMED	Class IIb	Active
Tissue Level Solid Abutment Lab Analog	S-TSALA40	EUDAMEDFDA UDI	Class I	Active
Bone Level Octa Abutment	S-BOA30	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Couple Abutment Wide Non-Octa	S-TCAWN40	EUDAMEDFDA UDI	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA3065(3)	EUDAMED	Class IIb	Active
L-reamer Drill	I-SIRL-45	EUDAMED	Class IIa	Active
Tissue Level Wide Premill Abutment	S-TWPA16	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA45407	EUDAMEDFDA UDI	Class IIb	Active
Multi Unit Impression Coping Transfer-Bridge	S-MUICT40-b	EUDAMED	Class I	Active
Tissue Level Fixture Lab Analog	S-TFLA	EUDAMEDFDA UDI	Class I	Active
i-system Healing Abutment	I-SHA4065(3)	EUDAMED	Class IIb	Active
Bone Level Mini Ti-Base Abutment	S-BMTiA20	EUDAMED	Class IIb	Active
Atrophic Maxillary Zygoma Implant	S-ZAM37.5	EUDAMED	Class IIb	Active
Profile Reamer Drill	I-SSR-40	EUDAMED	Class IIa	Active
I-Cement Removal Screw	I-SILCERSCR	EUDAMED	Class I	Active
Bone Level Narrow Healing Abutment	S-BNHA3530	EUDAMED	Class IIb	Active
Bone Level Premill Abutment	S-BPA14	EUDAMEDFDA UDI	Class IIb	Active
i-system Impression Post	I-SIPC(2)	EUDAMED	Class I	Active
Mono Implant Regular Rough	MOT4517	EUDAMED	Class IIb	Active
Tapered Drill	S-TD4810	EUDAMEDFDA UDI	Class IIa	Active
Octa Abutment Healing Cap	S-MUTCapL	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA4050-17(2.5)	EUDAMED	Class IIb	Active
I-Cement Abutment Scan Body Short	I-SILCEAPSB50S	EUDAMED	Class I	Active
Tapered Drill	S-TD4314	EUDAMEDFDA UDI	Class IIa	Active

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