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 Healing Abutment Wide	S-THAW35	EUDAMEDFDA UDI	Class IIb	Active
Mono Fixture Wide Smooth- Large Abutment	MS9014-LAb	EUDAMED	Class IIb	Active
Tissue Level Couple Abutment	S-TCA30	EUDAMEDFDA UDI	Class IIb	Active
Straight Drill	S-SD2810	EUDAMEDFDA UDI	Class IIa	Active
i-system Multi Unit Angled Abutment	I-SMUA2050-33(3)	EUDAMED	Class IIb	Active
Tissue Level Solid Abutment Large Cap	S-TSALCap70	EUDAMED	Class IIb	Active
i-system Digital Lab-Analog	I-SDLAb(2)	EUDAMED	Class I	Active
i-system i-LiNQ Angled Post	I-SIL150-15(2)	EUDAMED	Class IIb	Active
Mono Implant Rough -Oring Abutment	MOR3212	EUDAMED	Class IIb	Active
i-system Ball Abutment	I-SBA50(2.5)	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS9010	EUDAMED	Class IIb	Active
Bone Level Impression Coping Pickup Non-Hex Long	S-BICPN65L	EUDAMEDFDA UDI	Class I	Active
Tissue Level Solid Abutment Plastic Coping Crown	S-TSAPICc	EUDAMEDFDA UDI	Class I	Active
Mono Implant Regular Rough	MR4115	EUDAMED	Class IIb	Active
i-system i-LiNQ Angled Post	I-SIL075-15(2)	EUDAMED	Class IIb	Active
Tissue Level Impression Coping Transfer Guide Pin	S-TICTG14	EUDAMEDFDA UDI	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN4520	EUDAMEDFDA UDI	Class IIb	Active
L-reamer Drill	I-SIRL-40	EUDAMED	Class IIa	Active
i-system Ball Abutment	I-SBA60(2)	EUDAMED	Class IIb	Active
Mono Implant Regular Rough	MR4112	EUDAMED	Class IIb	Active
L-reamer Drill	I-SIRL-60	EUDAMED	Class IIa	Active
Tissue Level Impression Coping Pickup Guide Pin Long	S-TICPGL	EUDAMEDFDA UDI	Class I	Active
Monoimplant Ratchet	SK-RATCHET	EUDAMED	Class I	Active
Tissue Level Couple Abutment Wide Non-Octa	S-TCAWN30	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment Non-Hex	S-BAAN55252	EUDAMEDFDA UDI	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA3050-33(2)	EUDAMED	Class IIb	Active
Bone Level Couple Abutment Non-Hex	S-BCAN4510	EUDAMEDFDA UDI	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA6050-25(2)	EUDAMED	Class IIb	Active
Mono Implant Smooth -Micro	MSM3520- LAb	EUDAMED	Class IIb	Active
i-system Fixture	I-SF5004(3)	EUDAMED	Class IIb	Active
Pace Bone Level Multi Digital Lab Analog	S-PBMDLA	EUDAMED	Class I	Active
Bone Level Mini Abutment Screw	S-BMSAS	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Octa Abutment	S-BMOA40	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Short Impression Coping Guide Pin	S-BMSICTGP	EUDAMED	Class I	Active
Pace Impression Coping Pickup Non-Hex Long	S-PBICPN40L	EUDAMED	Class I	Active
Tissue Level Temporary Abutment	S-TTA40	EUDAMED	Class IIb	Active
Mono Implant Rough -Oring Abutment	MOR3710	EUDAMED	Class IIb	Active
Tissue Level Solid Abutment Impression Cap	S-TSAICap	EUDAMEDFDA UDI	Class I	Active
Pace Premill Scan Body Short	S-PPSBS	EUDAMED	Class I	Active
Tapered Aggressive Drill	S-TAD3712	EUDAMED	Class IIa	Active
Bone Level Mini Couple Abutment	S-BMCA5030	EUDAMED	Class IIb	Active
Bone Level Angled Abutment	S-BAA45154	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Couple Abutment	S-BCA55107	EUDAMEDFDA UDI	Class IIb	Active
i-system i-LiNQ Straight Post	I-SIL150(2)	EUDAMED	Class IIb	Active
Mono Implant Mini Smooth	MS3523	EUDAMED	Class IIb	Active
Bone Level Short Fixture Straight	S-BMFSR4805	EUDAMED	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU3010	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth	MS5517	EUDAMED	Class IIb	Active
i-system Locator Abutment	I-SLA20(2.5)	EUDAMED	Class IIb	Active
Mono Implant Regular Rough	MOT4520	EUDAMED	Class IIb	Active

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