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
Mono Implant Mini Smooth-Large Abutment	MS3510-LAb	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA5510	EUDAMEDFDA UDI	Class IIb	Active
i-system Shouldered Abutment Analog	I-SSAA6565	EUDAMED	Class I	Active
Tissue Level Abutment Screw	S-TAS	EUDAMEDFDA UDI	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA5050-33(3)	EUDAMED	Class IIb	Active
Tissue Level Solid Abutment Cap	S-TSACap55	EUDAMED	Class IIb	Active
Point Drill	S-PD3027	EUDAMED	Class IIa	Active
Bone Level Mini Locator Abutment	S-BMLA45	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Locator Abutment	S-BLA65	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Wide Fixture Hybrid	S-BWFHR5512	EUDAMEDFDA UDI	Class IIb	Active
Pace O-Ring Lab Analog	S-PORLA	EUDAMED	Class I	Active
Mono Implant Rough -Multi Unit Abutment	MMU3008	EUDAMED	Class IIb	Active
Octa Abutment Screw	S-OAS	EUDAMEDFDA UDI	Class IIb	Active
Pace Impression Coping Pickup Short	S-PBICP40S	EUDAMED	Class I	Active
i-system Miling Abutment	I-SMIA2050(2)	EUDAMED	Class IIb	Active
Tissue Level Octa Abutment	S-TOA	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Smooth -Micro	MSM3523- LAb	EUDAMED	Class IIb	Active
Mono Implant Regular Smooth-Large Abutment	MS4010-LAb	EUDAMED	Class IIb	Active
i-LiNQ Ratchet Adaptor	I-SILRA	EUDAMED	Class I	Active
Tissue Level Premill Abutment	S-TPA14	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini O-Ring Abutment	S-BMORA20	EUDAMEDFDA UDI	Class IIb	Active
Mono Implant Rough -Multi Unit Abutment	MMU3012	EUDAMED	Class IIb	Active
Bone Level Solid Abutment	S-BSA4540	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Mini Solid Abutment Plastic Coping Bridge	S-BMSAPƖC37b	EUDAMED	Class I	Active
Multi Unit Abutment Plastic Cylinder- Crown	S-MUPICy40-c	EUDAMED	Class I	Active
i-system Abutment Impression Coping	I-SAICP(2.5)	EUDAMED	Class I	Active
i-system Plug Remover Short	I-SPR-S	EUDAMED	Class I	Active
Pace Multi Unit Abutment Transfer Non Hex	S-PMUATN40	EUDAMED	Class I	Active
Retention Insert	S-LRI-b	EUDAMED	Class IIb	Active
i-system Fixture Analog	I-SFA(2)	EUDAMED	Class I	Active
i-LiNQ Connect Plastic Impression Cap	I-SILCOPIC	EUDAMED	Class I	Active
I-LiNQ Impression Post	I-SILIP40	EUDAMED	Class I	Active
i-system Ball Abutment	I-SBA20(2)	EUDAMED	Class IIb	Active
i-system i-LiNQ Straight Post	I-SIL225(2.5)	EUDAMED	Class IIb	Active
i-system Non- Shouldered Abutment	I-SNSA5050(2.5)	EUDAMED	Class IIb	Active
i-system Locator Abutment	I-SLA50(3)	EUDAMED	Class IIb	Active
i-LiNQ Connect Provisional Cylinder	I-SILCOPCyN	EUDAMED	Class I	Active
Bone Level Impression Coping Pickup Non-Hex Short	S-BICPN65S	EUDAMEDFDA UDI	Class I	Active
Bone Level Multi Unit Abutment Impression Pin	S-BMUAICPGpin	EUDAMEDFDA UDI	Class I	Active
i-system Shouldered Abutment Impression Cap	I-SAICP50	EUDAMED	Class I	Active
i-system Ti-Base Abutment	I-STiA3045(3)	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA3050-17(2)	EUDAMED	Class IIb	Active
Bone Level Ti-Base Abutment	S-BTiA10	EUDAMED	Class IIb	Active
i-system Fixture	I-SF3006(2)	EUDAMED	Class IIb	Active
Bone Level Narrow Temporary Abutment	S-BNTA35	EUDAMED	Class IIb	Active
Matrix Housing	S-LMHt	EUDAMEDFDA UDI	Class IIb	Active
Pace Impression Coping Octa Abutment Transfer Non Hex	S-PICOATN	EUDAMED	Class I	Active
Bone Level O-Ring Abutment	S-BORA40	EUDAMEDFDA UDI	Class IIb	Active
i-system Non-Shouldered Angled Abutment	I-SNSAA4065-15(3)	EUDAMED	Class IIb	Active
i-system Healing Abutment	I-SHA2050(2)	EUDAMED	Class IIb	Active

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