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 Fixture Hybrid	S-BFHR4308	EUDAMEDFDA UDI	Class IIb	Active
Straight Drill	S-SD4804	EUDAMED	Class IIa	Active
I-premill Scan Body Short	I-PSBS(3)	EUDAMED	Class I	Active
Tapered Aggressive Drill	S-TAD4814	EUDAMED	Class IIa	Active
Impression Coping Octa Abutment Pickup	S-ICOAP	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Couple Abutment Non-Hex	S-BMCAN37407	EUDAMED	Class IIb	Active
i-system Shouldered Abutment	I-SSA6050(2)	EUDAMED	Class IIb	Active
Pace Premill Octa Scan Body Short	S-PPOSBS	EUDAMED	Class I	Active
Lance Drill	S-LC3020	EUDAMED	Class IIa	Active
Bone Level Mini Couple Abutment	S-BMCA37207	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Solid Abutment Plastic Coping Crown	S-BMSAPƖC37c	EUDAMED	Class I	Active
Bar Housing	S-IBH	EUDAMEDFDA UDI	Class I	Active
i-system Shouldered Angled Abutment	I-SSAA4050-25(3)	EUDAMED	Class IIb	Active
i-LiNQ Locator Abutment	I-SILLAS	EUDAMED	Class IIb	Active
Neck Drill	S-ND5.5	EUDAMEDFDA UDI	Class IIa	Active
Tissue Level Temporary Abutment Non-Octa	S-TTAN20	EUDAMED	Class IIb	Active
Bone Level Mini Healing Abutment	S-BMHA6030	EUDAMED	Class IIb	Active
Bone Level Healing Abutment	S-BHA4550	EUDAMEDFDA UDI	Class IIb	Active
I-LiNQ Abutment Handle	I-LAH	EUDAMED	Class I	Active
Tissue Level Locator Abutment	S-TLA65	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU3712	EUDAMED	Class IIb	Active
Zygoma Implant	S-ZYG55	EUDAMED	Class IIb	Active
Bone Level Angled Abutment	S-BMUA48293	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Abutment	I-SILCEN50S	EUDAMED	Class IIb	Active
Tissue Level Short Fixture Straight	S-TFSR4805	EUDAMED	Class IIb	Active
Bone Level Mini Multi Abutment	S-BMMA37	EUDAMEDFDA UDI	Class IIb	Active
Neck Drill	S-ND4.8	EUDAMEDFDA UDI	Class IIa	Active
i-system Smart Abutment	I-SSRA6050(2)	EUDAMED	Class IIb	Active
Mono Implant Impression Components	MIC	EUDAMED	Class I	Active
i-system Multi Unit Abutment	I-SMUA5050(2.5)	EUDAMED	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA1050(2.5)	EUDAMED	Class IIb	Active
Bone Level Multi Abutment	S-BMUA4835	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA65407	EUDAMEDFDA UDI	Class IIb	Active
i-system Healing Abutment	I-SHA6040(2)	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Lab Analog	S-BSALA45	EUDAMEDFDA UDI	Class I	Active
Tissue Level Mini Locator Lab Analog	S-TLLA	EUDAMEDFDA UDI	Class I	Active
Bone Level Impression Coping Pickup Short	S-BICP45S	EUDAMEDFDA UDI	Class I	Active
I-Cement Impression Post	I-SILCEIP40	EUDAMED	Class I	Active
Bone Level Healing Abutment	S-BHA5540	EUDAMEDFDA UDI	Class IIb	Active
i-system Ball Abutment	I-SBA60(3)	EUDAMED	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA4050-15(2.5)	EUDAMED	Class IIb	Active
I-Cement Abutment	I-SILCEN40R	EUDAMED	Class IIb	Active
Bone Level Mini Sinus Abutment Screw	S-BMSIAS	EUDAMED	Class IIb	Active
Bone Level Mini Angled Abutment	S-BMAA37151	EUDAMEDFDA UDI	Class IIb	Active
Straight Drill	S-SD5504	EUDAMED	Class IIa	Active
Neck Drill	S-ND4.3	EUDAMEDFDA UDI	Class IIa	Active
Pace Bone Level Locator Lab Analog	S-PBLLA	EUDAMED	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN5510	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Regular Smooth	MS4012	EUDAMED	Class IIb	Active
i-reamer Drill	I-SIR-35	EUDAMED	Class IIa	Active

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