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 Couple Abutment	S-BMCA8020	EUDAMED	Class IIb	Active
Zygoma Implant	S-ZYG35	EUDAMED	Class IIb	Active
Tissue Level O-Ring Abutment	S-TORA20	EUDAMEDFDA UDI	Class IIb	Active
Tapered Drill	S-TD4814	EUDAMEDFDA UDI	Class IIa	Active
Bone Taping Drill	S-BT3217	EUDAMED	Class IIa	Active
Tapered Drill	S-TD5508	EUDAMEDFDA UDI	Class IIa	Active
Tissue Level Impression Coping Pickup Wide	S-TICPW	EUDAMEDFDA UDI	Class I	Active
i-system Multi Unit Angled Abutment	I-SMUA3050-33(2.5)	EUDAMED	Class IIb	Active
Multi Unit Impression Coping Transfer-Crown	S-MUICT-c	EUDAMED	Class I	Active
Tissue Level O-Ring Abutment	S-TORA40	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Conometric Abutment	I-SILCONO50L	EUDAMED	Class IIb	Active
Premill Multi Unit Scan Body Short	S-PMUSB48S	EUDAMED	Class I	Active
i-system Shouldered Abutment	I-SSA5065(3)	EUDAMED	Class IIb	Active
O-Ring Retainer/closed	S-LMHp	EUDAMED	Class IIb	Active
Bone Level Mini Couple Abutment	S-BMCA8030	EUDAMED	Class IIb	Active
Retention Insert	I-SLAR	EUDAMED	Class IIb	Active
i-reamer Drill	I-SIR-25	EUDAMED	Class IIa	Active
Tissue Level Couple Abutment Wide Non-Octa	S-TCAWN20	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment	S-ZMUA43171	EUDAMED	Class IIb	Active
Bone Level Mini Solid Abutment	S-BMSA3710	EUDAMEDFDA UDI	Class IIb	Active
Excellent Ball Ratchet Driver	S-BEBARD	EUDAMED	Class I	Active
Bone Level Mini Locator Abutment	S-BMLA55	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Mini Rough	MOT3510	EUDAMED	Class IIb	Active
Bone Level Temporary Abutment Non-Hex	S-BTAN45	EUDAMED	Class IIb	Active
Bone Level O-Ring Abutment	S-BEBA60	EUDAMED	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU4108	EUDAMED	Class IIb	Active
Mono Implant Mini Smooth	MS2729	EUDAMED	Class IIb	Active
I-Cement Angled Abutment	I-SILCE65R-15	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA2050-33(2)	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA5050-33(2)	EUDAMED	Class IIb	Active
i-system Smart Abutment	I-SSRA2050(2)	EUDAMED	Class IIb	Active
Atrophic Maxillary Zygoma Implant	S-ZAM60	EUDAMED	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS5523-LAb	EUDAMED	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA2065(3)	EUDAMED	Class IIb	Active
Pterygoid Implant	S-PTRY18	EUDAMED	Class IIb	Active
Tissue Level Couple Abutment Wide	S-TCAW40	EUDAMEDFDA UDI	Class IIb	Active
Bone Taping Drill	S-BT3710	EUDAMED	Class IIa	Active
i-system Fixture	I-SF6006(3)	EUDAMED	Class IIb	Active
i-system Shouldered Abutment Analog	I-SSAA5065	EUDAMED	Class I	Active
Tapered Aggressive Drill	S-TAD4314	EUDAMED	Class IIa	Active
I-Cement Impression Post	I-SILCEIP65	EUDAMED	Class I	Active
Point Drill	S-PD2527	EUDAMED	Class IIa	Active
Bone Level Mini Impression Coping Pickup Guide Pin Short	S-BMICPGS	EUDAMEDFDA UDI	Class I	Active
i-LiNQ Mono Fixture	I-MF3512	EUDAMED	Class IIb	Active
Mono Implant Rough -Oring Abutment	MOR3008	EUDAMED	Class IIb	Active
Pace Multi Unit Abutment Plastic Cylinder Non-Hex	S-PMUAPICYN48	EUDAMED	Class I	Active
Bone Level Angled Abutment	Bone Level Angled Abutment	EUDAMEDFDA UDI	Class IIb	Active
Point Drill	S-PD2027	EUDAMED	Class IIa	Active
Pilot Drill	I-SPD-08	EUDAMED	Class IIa	Active
Bone Level O-Ring Abutment	S-BEBA20	EUDAMED	Class IIb	Active

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