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
I-Cement Angled Abutment	I-SILCE65L-15	EUDAMED	Class IIb	Active
i-system i-LiNQ Angled Post	I-SIL375-15(2)	EUDAMED	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN5550	EUDAMEDFDA UDI	Class IIb	Active
Point Drill	S-PD3527	EUDAMED	Class IIa	Active
Drill Handle	S-HDL	EUDAMED	Class I	Active
Tissue Level Fixture Digital Lab-Analog	S-TFDLA	EUDAMEDFDA UDI	Class I	Active
i-system Knob	I-SKNB	EUDAMED	Class I	Active
Tissue Level Solid Abutment	S-TSA55	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Narrow Impression Coping Transfer Guide Pin	S-BNICTG	EUDAMED	Class I	Active
Bone Level Angled Abutment	S-BMUA48292	EUDAMED	Class IIb	Active
Mono Implant Mini Smooth	MS3514	EUDAMED	Class IIb	Active
Pace Abutment Lab Analog	S-PBMUALA40	EUDAMED	Class I	Active
Pace Abutment Impressıon Coping Pick Up	S-PBMUAICP40	EUDAMED	Class I	Active
Bone Level Solid Abutment Lab Analog	S-BSALA55	EUDAMEDFDA UDI	Class I	Active
Excellent Ball Block Out Ring	S-EBBO-Ring	EUDAMED	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN6550	EUDAMEDFDA UDI	Class IIb	Active
Bar Burnout	S-IB	EUDAMEDFDA UDI	Class I	Active
Bone Level Angled Abutment Non-Hex	S-BAAN65252	EUDAMEDFDA UDI	Class IIb	Active
Excellent Ball Path Guide Ring	S-EBPG-Ring	EUDAMED	Class I	Active
Bone Level Multi Digital Lab Analog	S-BMDLA	EUDAMEDFDA UDI	Class I	Active
i-system Mandibular Extraction Forceps	I-SFRCU	EUDAMED	Class I	Active
Premill Mini Scan Body Short	S-PMSBS	EUDAMED	Class I	Active
Multi Unit Impression Coping Pick Up - Bridge	S-MUICP40-b	EUDAMED	Class I	Active
i-system Shouldered Abutment	I-SSA6040(2.5)	EUDAMED	Class IIb	Active
Bone Level Mini Impression Coping Pickup Non-Hex Short	S-BMICPN37S	EUDAMEDFDA UDI	Class I	Active
Abutment Handle	S-HDL45	EUDAMED	Class I	Active
Bone Level Mini Locator Abutment	S-BMLA35	EUDAMEDFDA UDI	Class IIb	Active
Pace Bone Level Fixture Digital Lab Analog	S-PBFDLA	EUDAMED	Class I	Active
Tissue Level Solid Abutment	S-TSA70	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Locator Abutment	S-TLA55	EUDAMEDFDA UDI	Class IIb	Active
I-Cement Angled Abutment	I-SILCE40R-15	EUDAMED	Class IIb	Active
Tissue Level Impression Coping Transfer	S-TICT	EUDAMEDFDA UDI	Class I	Active
Lance Drill	S-LC2020	EUDAMED	Class IIa	Active
Abutment Impression Coping Pick Up	S-BMUAICP	EUDAMEDFDA UDI	Class I	Active
Bone Level Impression Coping Pickup Non-Hex Long	S-BICPN45L	EUDAMEDFDA UDI	Class I	Active
Bone Level Solid Abutment Impression Cap	S-BSAICap45	EUDAMEDFDA UDI	Class I	Active
Bone Level Solid Abutment	S-BSA6510	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA6540	EUDAMEDFDA UDI	Class IIb	Active
Locator and ORRo Insert Adaptor	S-OIA	EUDAMEDFDA UDI	Class I	Active
i-system Multi Unit Angled Abutment	I-SMUA2050-17(2.5)	EUDAMED	Class IIb	Active
Pace Impression Coping Pickup Long	S-PBICP50L	EUDAMED	Class I	Active
Bone Level Angled Abutment	S-BMUA48171	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Solid Abutment	S-BSA6520	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Impression Coping Transfer Cap	S-BMICTGCap	EUDAMEDFDA UDI	Class I	Active
Tissue Level O-Ring Abutment	S-TEBA40	EUDAMED	Class IIb	Active
Bone Level Impression Coping Pickup Guide Pin Short	S-BICPGS	EUDAMEDFDA UDI	Class I	Active
lmplantswiss Dental Short lmplant Surgical Kit	S-BTSSK	EUDAMED	Class I	Active
Bone Level O-Ring Abutment	S-BORA20	EUDAMEDFDA UDI	Class IIb	Active
lmplantswiss Dental lmplant Surgical Kit	S-BTSK	EUDAMEDFDA UDI	Class I	Active
Bone Level Angled Abutment	S-BMUA48351	EUDAMED	Class IIb	Active

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