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
Tissue Level Short Fixture Straight	S-TFSR4806	EUDAMED	Class IIb	Active
Bone Level Healing Abutment	S-BHA6550	EUDAMEDFDA UDI	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA4050-25(2)	EUDAMED	Class IIb	Active
Bone Level Fixture Digital Lab Analog	S-BFDLA	EUDAMEDFDA UDI	Class I	Active
Premill Multi Unit Scan Body Long	S-PMUSB40L	EUDAMED	Class I	Active
Zygoma Abutment Screw	S-ZMUAS	EUDAMED	Class IIb	Active
Bone Level Healing Abutment	S-BHA6540	EUDAMEDFDA UDI	Class IIb	Active
Large Abutment Handle	S-HDL55	EUDAMED	Class I	Active
Bone Level O-Ring Abutment	S-BEBA40	EUDAMED	Class IIb	Active
i-system Abutment Handle	I-SAH	EUDAMED	Class I	Active
Tissue Level Wide Premill Abutment	S-TWPA14	EUDAMEDFDA UDI	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA4040(2.5)	EUDAMED	Class IIb	Active
Twist Drill	S-TWD2965	EUDAMED	Class IIa	Active
Bone Level Fixture Lab Analog	S-BFLA	EUDAMEDFDA UDI	Class I	Active
Octa Abutment Healing Cap	S-OAHCap	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Mini Rough	MR3215	EUDAMED	Class IIb	Active
i-LiNQ Conometric Cap	I-SILCONOC-15	EUDAMED	Class IIb	Active
Bar Positioning	S-IBP	EUDAMEDFDA UDI	Class I	Active
Bone Level Octa Abutment	S-BOA40	EUDAMEDFDA UDI	Class IIb	Active
Tapered Drill	S-TD4812	EUDAMEDFDA UDI	Class IIa	Active
Tapered Drill	S-TD4308	EUDAMEDFDA UDI	Class IIa	Active
Mono Implant Regular Smooth	MS4514	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA4530	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Mini Rough	MR3212-B	EUDAMED	Class IIb	Active
Implantswiss Dental Implant System, Implantswiss Dental Abutment System	K181266	FDA 510(k)	Class II	Active
Implantswiss Dental Implant System and Implantswiss Dental Abutment System	K200867	FDA 510(k)	Class II	Active
Octa Abutment Healing Cap	S-MUAHCap	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Solid Abutment	S-BSA4520	EUDAMEDFDA UDI	Class IIb	Active
Straight Drill	S-SD2208	EUDAMEDFDA UDI	Class IIa	Active
i-system Multi Unit Abutment	I-SMUA4050(2)	EUDAMED	Class IIb	Active
Bone Level Mini Locator Abutment	S-BMLA15	EUDAMEDFDA UDI	Class IIb	Active
Monoimplant Multi Unit Plastic Cylinder	MMUAPICy	EUDAMED	Class I	Active
i-LiNQ Mono Fixture	I-MF6012	EUDAMED	Class IIb	Active
Tissue Level Healing Abutment	S-THA30	EUDAMEDFDA UDI	Class IIb	Active
Impression Coping Octa Abutment Transfer	S-ICOAT	EUDAMEDFDA UDI	Class I	Active
Bone Level Impression Coping Pickup Short	S-BICP65S	EUDAMEDFDA UDI	Class I	Active
i-system i-LiNQ Straight Post	I-SIL375(2.5)	EUDAMED	Class IIb	Active
Bone Level Angled Abutment	S-BAA45254	EUDAMEDFDA UDI	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA4050-33(2)	EUDAMED	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU3710	EUDAMED	Class IIb	Active
I-Cement Abutment Scan Body Long	I-SILCEAPSB65L	EUDAMED	Class I	Active
Bone Level Angled Abutment Non-Hex	S-BAAN45154	EUDAMEDFDA UDI	Class IIb	Active
i-system Locator Abutment	I-SLA30(2)	EUDAMED	Class IIb	Active
Tissue Level Angled Abutment	S-TAA25	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA6550	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment	S-BAA45152	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN6530	EUDAMEDFDA UDI	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA4040(2)	EUDAMED	Class IIb	Active
Tissue Level Impression Coping Pickup Non-Octa	S-TICPN	EUDAMEDFDA UDI	Class I	Active
Bone Level Mini Solid Abutment	S-BMSA3750	EUDAMEDFDA UDI	Class IIb	Active

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