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-system Abutment Impression Coping	I-SAICP(3)	EUDAMED	Class I	Active
Pace Impression Coping Transfer Guide Pin Long	S-PBICTGL	EUDAMED	Class I	Active
i-system Impression Post	I-SIP(3)	EUDAMED	Class I	Active
Excellent Ball Lab Analog	S-EBLA	EUDAMED	Class I	Active
Bone Level Impression Coping Transfer Cap	S-BICTGCap	EUDAMEDFDA UDI	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN55507	EUDAMED	Class IIb	Active
Ti-Base Mini Scan Body	S-TiMSB	EUDAMED	Class I	Active
i-LiNQ Conometric Cap	I-SILCONOC	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Plastic Coping Bridge	S-BSAPIC45b	EUDAMEDFDA UDI	Class I	Active
i-system Multi Unit Abutment	I-SMUA5050(3)	EUDAMED	Class IIb	Active
Tissue Level Wide Fixture Hybrid	S-TWFHR5512	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ connect Abutments	I-SILCOR-17	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA4050-33(3)	EUDAMED	Class IIb	Active
Mono Implant Regular Rough	MOT4514	EUDAMED	Class IIb	Active
i-LiNQ Mono Fixture	I-MF3014	EUDAMED	Class IIb	Active
Straight Drill	S-SD2805	EUDAMED	Class IIa	Active
Multi Unit Abutment Transfer Non Hex	S-MUATN40	EUDAMED	Class I	Active
Bone Taping Drill	S-BT3015	EUDAMED	Class IIa	Active
Tissue Level Solid Abutment Large Lab Analog	S-TSALLA55	EUDAMEDFDA UDI	Class I	Active
Bone Level Solid Abutment	S-BSA4550	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Angled Abutment	S-BAA55152	EUDAMEDFDA UDI	Class IIb	Active
i-system i-LiNQ Straight Post	I-SIL225(3)	EUDAMED	Class IIb	Active
Bone Level Narrow Impression Coping Pick up Guide Pin	S-BNICPG	EUDAMED	Class I	Active
Bone Level Healing Abutment	S-BHA6530	EUDAMEDFDA UDI	Class IIb	Active
i-system Ti-Base Abutment	I-STiA1045(2)	EUDAMED	Class IIb	Active
Bone Level Angled Abutment Non-Hex	S-BAAN55254	EUDAMEDFDA UDI	Class IIb	Active
I-LiNQ Impression Post peek	I-SILIPpe	EUDAMED	Class I	Active
Zygoma Implant	S-ZYG60	EUDAMED	Class IIb	Active
Point Drill	S-PD2517	EUDAMED	Class IIa	Active
O-Ring Retainer/open	S-ORRo	EUDAMEDFDA UDI	Class IIb	Active
i-system Fixture	I-SF4010(2.5)	EUDAMED	Class IIb	Active
Tissue Level Couple Abutment Non-Octa	S-TCAN10	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ connect Healing Caps	I-SILCOHC	EUDAMED	Class IIb	Active
Bone Level Mini Couple Abutment	S-BMCA6030	EUDAMED	Class IIb	Active
Tissue Level Wide Fixture Hybrid	S-TWFHR5510	EUDAMEDFDA UDI	Class IIb	Active
i-system Locator Abutment	I-SLA30(3)	EUDAMED	Class IIb	Active
Retention Insert	S-LRI	EUDAMEDFDA UDI	Class IIb	Active
Pace Abutment Impressıon Coping Pick Up	S-PBMUAICP48	EUDAMED	Class I	Active
i-system Shouldered Angled Abutment	I-SSAA6065-15(3)	EUDAMED	Class IIb	Active
i-system Multi Unit Angled Abutment	I-SMUA1050-17(3)	EUDAMED	Class IIb	Active
Zygoma Straight Handle	S-ZDIS	EUDAMED	Class I	Active
Bone Level Mini Impression Coping Transfer Long	S-BMICT37L	EUDAMEDFDA UDI	Class I	Active
Tissue Level Angled Abutment	S-TAA15	EUDAMEDFDA UDI	Class IIb	Active
I-premill Scan Body	I-PSB(3)	EUDAMED	Class I	Active
i-LiNQ Conometric Abutment	I-SILCONO65S	EUDAMED	Class IIb	Active
Mono Implant Mini Rough	MOT3512	EUDAMED	Class IIb	Active
Tissue Level Fixture Hybrid	S-TFHR3712	EUDAMEDFDA UDI	Class IIb	Active
Abutment Impression Coping Pick Up Guide Pin	S-BMICPGPIN	EUDAMEDFDA UDI	Class I	Active
Mono Implant Regular Rough	MR3712-B	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Short Fixture Straight	S-BMFSR5505	EUDAMED	Class IIb	Active

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