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 Couple Abutment Wide	S-TCAW20	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Narrow Ti-Base Abutment	S-BNTiA20	EUDAMED	Class IIb	Active
Tissue Level Solid Abutment Lab Analog	S-TSALA55	EUDAMEDFDA UDI	Class I	Active
Excellent Ball Impression Sheet	S-EBIS	EUDAMED	Class I	Active
Tissue Level Fixture Hybrid	S-TFHR4308	EUDAMEDFDA UDI	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA3040(2)	EUDAMED	Class IIb	Active
i-system Multi Unit Abutment Analog	I-SMUALA	EUDAMED	Class I	Active
Mono Implant Regular Rough	MR3708	EUDAMED	Class IIb	Active
Multi Unit Abutment Plastic Cylinder- Bridge	S-MUPICy-b	EUDAMED	Class I	Active
Pace Ti-Base Scan Body Short	S-PTiSBS	EUDAMED	Class I	Active
i-LiNQ Mono Fixture	I-MF4010	EUDAMED	Class IIb	Active
i-LiNQ Dental Implant Surgical Kit	I-SILSK	EUDAMED	Class I	Active
I-Cement Abutment	I-SILCEN40S	EUDAMED	Class IIb	Active
Bone Level Aggressive Reamer Drill	S-BARD3.7	EUDAMED	Class IIa	Active
Bone Level Couple Abutment Non-Hex	S-BCAN45307	EUDAMED	Class IIb	Active
Twist Drill	S-TWD3565	EUDAMED	Class IIa	Active
Pace Impression Coping Transfer Long	S-PBICT50L	EUDAMED	Class I	Active
I-Connect Abutment Protective Cap	I-SILCOPRCap	EUDAMED	Class I	Active
i-LiNQ Ball Abutment Analog	I-SILBAA	EUDAMED	Class I	Active
Mono Fixture Wide Smooth- Large Abutment	MS9008-LAb	EUDAMED	Class IIb	Active
i-system Multi Unit Abutment Impression Pick Up	I-SMUAIP	EUDAMED	Class I	Active
Pace Ti-Base Scan Body Long	S-PTiSBL	EUDAMED	Class I	Active
Bone Level Octa Abutment	S-BOA10	EUDAMEDFDA UDI	Class IIb	Active
Pilot Drill	I-SPD-06	EUDAMED	Class IIa	Active
Bone Level Mini Impression Coping Pickup Long	S-BMICP37L	EUDAMEDFDA UDI	Class I	Active
Bone Level Narrow Couple Abutment	S-BNCA35307	EUDAMED	Class IIb	Active
Monoimplant Hex Ratchet Driver Short	M-12HDRS	EUDAMED	Class I	Active
Mono Implant Mini Rough	MR3215-B	EUDAMED	Class IIb	Active
Bone Taping Drill	S-BT4910	EUDAMED	Class IIa	Active
Bone Level Healing Abutment	S-BHA5550	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Abutment	I-SSA5040(2)	EUDAMED	Class IIb	Active
i-LiNQ Conometric Abutment	I-SILCONO65L	EUDAMED	Class IIb	Active
Bone Level Mini Short Impression Pickup Guide Pin	S-BMSICPGP	EUDAMED	Class I	Active
i-LiNQ Healing Cap	I-SILHC40L	EUDAMED	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS7010 -LAb	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA5550	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Conometric Digital Lab Analog	I-SILCONODLA	EUDAMED	Class I	Active
Mono Implant Mini Smooth-Large Abutment	MS3517- LAb	EUDAMED	Class IIb	Active
i-LiNQ Conometric Cap Analog	I-SILCONOCAPA	EUDAMED	Class I	Active
Broken Help Kit Guide Handle	S-BHKGHDL	EUDAMED	Class I	Active
Mono Implant Regular Rough	MR4908	EUDAMED	Class IIb	Active
Bone Level Mini Multi Abutment NON-HEX	S-BMMAN37	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Angled Abutment	I-SSAA6040-15(2)	EUDAMED	Class IIb	Active
Bone Level Fixture Hybrid	S-BFHR3708	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA55307	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Healing Abutment	S-THA55	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Ti-Base Abutment	S-BTiA05	EUDAMED	Class IIb	Active
Bone Level Mini Impression Coping Pickup Guide Pin Long	S-BMICPGL	EUDAMEDFDA UDI	Class I	Active
Tissue Level Couple Abutment Wide Non-Octa	S-TCAWN10	EUDAMEDFDA UDI	Class IIb	Active
L-reamer Drill	I-SIRL-35	EUDAMED	Class IIa	Active

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